Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO GROSS ASEPTIC LOOSENING. Manufacturer 1822565-2015- 00224 PERSONA STEMMED CEMENTED TIBIAL COMPONENT 2/23/15 1/21/15 Injury Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS MW5040892 PERSONA 2/19/15 2/5/14 Injury Event Description: RECEIVED A RIGHT KNEE REPLACEMENT WITH A ZIMMER PERSONA DEVICE; LOT # 56586565;(B)(4) ON (B)(6) 2014. CONTINUED TO HAVE SEVERE PAIN POST SURGERY ON LATERAL SIDE TO TIBIA AREA. ADDITIONAL SURGERY (ARTHROSCOPY) PERFORMED ON (B)(6) 2014 WHERE PHYSICIAN RELEASED POPLITEUS TENDON; THIS DID NOT RECTIFY PROBLEM AND PAIN PERSISTED. ANOTHER ARTHROSCOPIC SURGERY PERFORMED ON (B)(6) 2014 TO REMOVE LATERAL CEMENT MANTLE WHICH WAS THOUGHT TO BE CAUSING IMPINGEMENT THE LOWER RIGHT SIDE OF THE KNEE. A LATERAL RETINACULAR RELEASE WAS ALSO PERFORMED DURING THIS SURGERY. TO DATE; THERE REMAINS SEVERE PAIN IN THE LOWER LATERAL AREA OF THIS RIGHT KNEE THAT ALL THE SURGERIES HAVE NOT IMPROVED UPON. KNEE CONTINUES TO HAVE INFLAMMATION REQUIRING FREQUENT ICING AND INABILITY TO STAND OR SIT FOR PERIODS LONGER THAN ONE HOUR. C- REACTIVE PROTEIN BLOOD TESTS SHOW CONTINUED ELEVATION AS A MARKER FOR INFLAMMATION. CONTINUED DISABILITY FROM NORMAL DAILY ACTIVITIES AND UNABLE TO RETURN TO WORK. PAIN MEDICATION IS STILL BEING PRESCRIBED AND IS NECESSARY DUE TO SEVERITY OF CONTINUED PAIN RESULTING FROM KNEE REPLACEMENT. 1822565-2015- 00131 PERSONA CR POROUS FEMORAL COMPONENT 2/4/15 1/7/15 Injury Event Description: IT WAS REPORTED THAT THE PT'S KNEE WAS REVISED DUE TO FEMORAL COMPONENT FIXATION LOSS. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2015- 00119 UNKNOWN TM PERSONA TIBIA COMPONENT 2/3/15 Injury Event Description: IT IS REPORTED THAT AN UNK NUMBER OF PTS WERE EXPERIENCING ROCKING TIBIA COMPONENTS AND OR RADIOLUCENT LINES. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUT INVESTIGATION IS Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT WAS 1822565-2015- 00101 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 1/27/15 12/23/14 Malfunction REPORTED THAT THE INSTRUMENT IS MISSING A BALL BEARING. 1822565-2015- 00100 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 1/27/15 Event Description: IT IS REPORTED THAT UPON INSPECTION THE SHIMS WERE FOUND TO HAVE BALL BEARINGS MISSING. 12/22/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2015- 00085 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 1/21/15 Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACE PROVISIONAL SHIM WAS DISCOVERED TO BE MISSING ONE OF THE BALL BEARINGS AFTER THE CLEANING PROCESS. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR 12/19/14 Malfunction INVESTIGATION IS 1822565-2015- 00092 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 1/21/15 Event Description: IT WAS REPORTED THAT UPON INSPECTION; TWO SHIMS WERE FOUND TO HAVE BQALL BEARINGS MISSING. 12/1/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2015- 00089 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 1/21/15 Event Description: IT IS REPORTED THAT THE SHIM LOST A BEARING DURING THE CLEANING PROCESS. Manufacturer Narrative: 12/18/14 Malfunction THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2015- 00088 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 1/21/15 Event Description: IT IS REPORTED THAT THE SHIM WAS FOUND TO BE MISSING A BALL BEARING. Manufacturer Narrative: 12/17/14 Malfunction THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2015- 00091 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 1/21/15 Event Description: IT WAS REPORTED THAT UPON INSPECTION; TWO SHIMS WERE FOUND TO HAVE BALL BEARINGS MISSING. 12/22/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO A LOOSE TIBIA COMPONENT. Manufacturer Narrative: 1822565-2015- 00087 PERSONA PEGGED POROUS TIBIAL COMPONENT 1/21/15 12/17/14 Injury THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT WAS REPORTED THAT THE STERILE PROCESSING COORDINATOR NOTICED THAT THE SHIM WAS MISSING ITS BALL BEARING AFTER THE 1822565-2015- 00074 PERSONA TIBIAL ARTICULAR SURFACE SHIM 1/16/15 12/17/14 Malfunction INSTRUMENT WENT THROUGH THE CLEANING AND DISINFECTING PROCESS. 1822565-2015- 00076 PERSONA TIBIAL ARTICULAR SURFACE SHIM 1/16/15 Event Description: IT WAS REPORTED THAT IT WAS DISCOVERED DURING A KIT INSPECTION THAT THE SHIM WAS MISSING BALL 12/17/14 Malfunction BEARINGS. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED RIGHT SIDE IMPLANTS WERE IMPLANTED DURING A LEFT TOTAL KNEE SURGERY. THE PATIENT WAS BROUGHT BACK INTO SURGERY AND THOSE PARTS WERE REMOVED AND CORRECT DEVICES WERE IMPLANTED. 1822565-2015- 00078 PERSONA CRUCIATE RETAINING CEMENTED FEMUR 1/16/15 12/16/14 Injury Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT UPON OPENING THE IMPLANTS FOR SURGERY; A DISCOLORATION WAS SEEN ON BOTH 2648920-2015- 00012 PERSONA STEMMED CEMENTED TIBIAL COMPONENT 1/14/15 12/15/14 Malfunction DEVICES. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING. Manufacturer Narrative: THIS REPORT 2648920-2015- 00010 PERSONA CEMENTED STEMMED TIBIAL PLATE 1/14/15 12/3/14 Injury WILL BE AMENDED WHEN OUR INVESTIGATION IS Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT WAS 1822565-2015- 00036 PERSONA TIBIA ARTICULAR SURFACE INSERTER 1/13/15 12/15/14 Malfunction REPORTED THAT THE BALL BEARING IS MISSING FROM THE ARTICULAR SURFACE INSERTER. 1822565-2015- 00037 PERSONAL ARTICULAR SURFACE INSERTER 1/13/15 Event Description: IT WAS REPORTED THAT A BALL BEARING IS MISSING FROM THE ARTICULAR SURFACE PROVISIONAL SHIM. 12/15/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2015- 00038 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 1/13/15 Event Description: IT IS REPORTED THAT THE INSTRUMENT WAS MISSING THE SHIM BALL BEARINGS. Manufacturer Narrative: 12/15/14 Malfunction THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATOR IS Event Description: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO A FAILURE OF THE TIBIAL COMPONENT. 1822565-2015- 00032 PERSONA 2 PEG POROUS TIBIAL COMPONENT 1/9/15 12/16/14 Injury Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2015- 00028 UNKNOWN PERSONA TIBIA 1/9/15 Injury Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN BEYOND SIX WEEKS AFTER SURGERY. SURGEON SUSPECTS POPLITEAL IMPINGEMENT; BUT HE THINKS THE OTHER PART IS A BASEPLATE WITH TOO MUCH MOTION. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2015- 00007 PERSONA PEGGED POROUS TIBIAL COMPONENT 1/7/15 9/2/14 Injury Event Description: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT SEAT INTO THE TIBIAL TRAY. Manufacturer 1822565-2014- 01835 PERSONA UC VIVACIT- E ARTICULAR SURFACE 12/23/14 12/2/14 Malfunction Narrative:. 1822565-2014- 01828 PERSONA TIBIAL ARTICULAR SURFACE SHIM 12/23/14 Event Description: IT IS REPORTED THAT AFTER BEING PUT THROUGH THE SONIC CLEANER; SOME OF THE BEARINGS WERE 11/25/14 Malfunction MISSING. Manufacturer Narrative:. 1822565-2014- 01827 PERSONA PS VIVACIT- E ARTICULAR SURFACE 12/23/14 Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT LOCK INTO THE TIBIAL BASEPLATE. 12/2/14 Malfunction Manufacturer Narrative:. 1822565-2014- 01810 PERSONA PEGGED POROUS TIBIAL PLATE 12/19/14 Injury THIS PATIENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE SURGEON FEELS THIS INSTRUMENT MAY ALLOW IMPROPER ROTATION RESULTLING IN MALPOSITION. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01777 PERSONA A- REF FEMORAL SIZER 12/18/14 Malfunction 1822565-2014- 01776 PERSONA TIBIAL ARTICULAR SURFACE INSERTER 12/18/14 Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACE INSERTER TIP HAD BROKEN OFF. Manufacturer Narrative: 11/19/14 Malfunction THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 2648920-2014- 00411 PERSONA CRUCIATE RETAINING ART SURGACE 12/18/14 Event Description: IT IS REPORTED THAT THE SURGEON FELT THE PERMANENT IMPLANT DID NOT HAVE THE EXACT SAME MEASUREMENTS AS THE TRIAL COMPONENT. A THICKER PERMANENT IMPLANT WAS USED. Manufacturer Narrative: THIS 11/20/14 Malfunction REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 2648920-2014- 00403 PERSONA POSTERIOR STABILIZED ART SURFACE 12/18/14 Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT LOCK INTO POSITION ON THE TIBIAL PLATE. 11/26/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01805 PERSONA ANTERIOR REFERENCING SIZER 12/18/14 REPORTED THAT WHILE THE SURGEON MADE THE DISTAL FEMORAL CUT AND WAS USING THE AP SIZING; HE FELT THERE WAS EXCESSIVE MOVEMENT OF THE SIZING GUIDE. HE FOUND A NEUTRAL POSITION IN THE GUIDE AND DRILLED THE HOLES AND THE 10/2/14 Malfunction CASE CONTINUED AS NORMAL. Event Description: IT IS REPORTED THAT THE SURGEON IS CONCERNED ABOUT RADIOLUCENCY HE HAS OBSERVED ON X- RAYS 1822565-2014- 01791 PERSONA PEGGED POROUS TIBIAL PLATE 12/18/14 12/2/14 Injury FOR THIS PATIENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01786 PERSONA PEGGED POROUS TIBIAL PLATE 12/18/14 Injury REPORTED THAT THE SURGEON IS CONCERNED ABOUT RADIOLUCENCY HE WAS OBSERVED ON THE X- RAYS FOR THIS PT. 1822565-2014- 01788 PERSONA PEGGED POROUS TIBIAL COMPONENT 12/18/14 11/25/14 Injury Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01787 PERSONA PEGGED POROUS TIBIAL PLATE 12/18/14 Injury Event Description: IT IS REPORTED THAT THE SURGEON IS CONCERNED ABOUT RADIOLUCENCY HE HAS OBSERVED ON THE X- RAYS FOR THIS PT. Manufacturer Narrative: INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01792 UNKNOWN PERSONA TM MODULAR TIBIAL PLATE 12/18/14 Injury Event Description: IT IS REPORTED THAT THE SURGEON HAS CONCERNS ABOUT THE TIBIAL COMPONENT THAT APPEARS TO HAVE COLLAPSED. Manufacturer Narrative: INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01790 PERSONA PEGGED POROUS TIBIAL PLATE 12/18/14 Injury REPORTED THAT THE SURGEON IS CONCERNED ABOUT RADIOLUCENCY HE HAS OBSERVED ON THE X- RAYS FOR THIS PT. 1822565-2014- 01804 PERSONA PS VIVACIT- E ARTICULAR SURFACE 12/18/14 11/20/14 Injury Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND SWELLING. ADDITIONALLY; IT IS NOTED THAT THE PT HAD A KNEE MANIPULATION PERFORMED AT SOME POINT IN BETWEEN THE TIME OF THE PRIMARY SURGERY AND THE ARTICULAR SURFACE EXCHANGE. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT FOLLOWING STERILIZATION; THE SHIM IS MISSING ONE OF ITS BALL BEARINGS. 1822565-2014- 01766 PERSONA TIBIAL ARTICULAR SURFACE SHIM 12/16/14 11/10/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN. Manufacturer Narrative: THIS REPORT WILL BE 1822565-2014- 01756 PERSONA CR CEMENTED FEMORAL COMPONENT 12/16/14 Injury AMENDED WHEN OUR INVESTIGATION IS Event Description: IT WAS REPORTED THAT THE HOOK OF THE INSERTER WAS DEFORMED. Manufacturer Narrative: THIS 1822565-2014- 01747 PERSONA TIBIAL ARTICULAR SURFACE INSERTER 12/15/14 Malfunction REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS
Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT WAS 1822565-2014- 01739 PERSONA PEGGED POROUS TIBIAL COMPONENT 12/11/14 7/16/14 Injury REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING. Event Description: IT IS REPORTED THAT THE SURGEON FEELS THERE IS TOO MUCH PLAY IN THIS INSTRUMENT AND HAS THE POTENTIAL TO CAUSE IMPROPER ROTATION RESULTING IN MALPOSITION. Manufacturer Narrative: THIS REPORT WILL BE 1822565-2014- 01726 PERSONA A- REF FEMORAL SIZER 12/10/14 Malfunction AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01727 PERSONA A- REF FEMORAL SIZER 12/10/14 Event Description: IT IS REPORTED THAT THE SURGEON FEELS THERE IS TOO MUCH PLAY IN THIS INSTRUMENT AND HAS THE POTENTIAL TO CAUSE IMPROPER ROTATION RESULTING IN MALPOSITION. Manufacturer Narrative: THIS REPORT WILL BE Malfunction AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01725 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 12/10/14 Event Description: IT IS REPORTED THAT THE SHIM BALL BEARINGS DISASSEMBLED FROM THE INSTRUMENT DURING STERILIZATION AT THE HOSPITAL. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 11/12/14 Malfunction 1822565-2014- 01733 PERSONA HIGHLY CROSSLINKED ART SURFACE 12/10/14 Event Description: IT IS REPORTED THAT THE TIBIA SUBLUXED FORWARD BECAUSE OF A SURFACE MATERIAL ISSUE. 10/30/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01699 PERSONA UC VIVACIT - E ARTICULAR SURFACE 12/5/14 Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACES WOULD NOT ENGAGE PROPERLY TO THE TIBIAL TRAY. 11/3/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01694 PERSONA CEMENTED TIBIAL BROACH 12/4/14 Event Description: IT IS REPORTED THAT A STAFF MEMBER NOTICED THAT PART OF THE STAINLESS STEEL ON THE TIBIAL BROACH WAS BROKEN. ACCORDING TO THE SURGEON; NO METAL WAS LEFT IN THE PATIENT'S BODY. Manufacturer Narrative: 11/4/14 Malfunction THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01698 PERSONA TIBIA ARTICULAR SURFACE PROVISIONAL 12/4/14 11/4/14 Malfunction REPORTED THAT THE TRIAL ARTICULAR SURFACE SHIM WAS MISSING ONE OF THE BALL BEARINGS. Event Description: IT IS REPORTED THAT THE PT WAS REVISED FOR AN UNK REASON. Manufacturer Narrative: THIS REPORT 1822565-2014- 01688 PERSONA PS VIVACIT- E ARTICULAR SURFACE 12/4/14 8/31/14 Injury WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01676 PERSONA PEGGED POROUS TIBIAL COMPONENT 12/2/14 11/3/14 Injury Manufacturer Narrative: INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO A SUBSIDED TIBIAL COMPONENT; MALALIGNMENT; AND PAIN. 1822565-2014- 01671 PERSONA CEMENTED STEMMED TIBIAL PLATE 11/25/14 7/29/14 Injury Manufacturer Narrative: INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FROM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO TIBIA LOOSENING. Event Description: IT IS REPORTED THAT A STAFF MEMBER NOTED DURING THE STERILIZATION PROCESS THAT MANY TEETH OF THE TIBIAL BROACH WERE BROKEN. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01653 PERSONA CEMENTED TIBIAL BROACH 11/24/14 10/28/14 Malfunction 1822565-2014- 01655 PERSONA TIBIAL ARTICULAR SURFACE SHIM 11/24/14 10/24/14 Malfunction REPORTED THAT THE BALL BEARING FELL OUT IN A WASH. 1822565-2014- 01654 PERSONA TIBIA ARTICULAR SURFACE INSERTER 11/24/14 Malfunction REPORTED THAT THE INSTRUMENT IS MISSING A BALL BEARING IN THE BACK OF THE PIECE. 2648920-2014- 00331 PERSONA CEMENTED STEMMED TIBIAL PLATE 11/24/14 REPORTED THAT THE OUTER; HARD PLASTIC BOX WAS MISSING FROM THE DEVICE PACKAGING; THUS COMPROMISING THE 10/29/14 Malfunction STERILITY OF THE IMPLANT. 1822565-2014- 01638 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 11/20/14 Event Description: IT IS REPORTED THAT THE BALL BEARINGS WERE MISSING FROM THE INSTRUMENTS. Manufacturer Malfunction Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO A LOOSE TIBIAL COMPONENT. Manufacturer 1822565-2014- 01627 UNKNOWN PERSONA TM TIBIAL COMPONENT 11/20/14 10/10/14 Injury Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACE WOULD NOT PROPERLY SEAT IN THE BASEPLATE. THE POLY WAS REMOVED AND BASEPLATE IRRIGATED AND IMPLANTATION WAS ATTEMPTED AGAIN. THE POLY STILL WOULD NOT FULLY SEAT INTO BASEPLATE. ANOTHER POLY WAS OPENED AND SUCCESSFULLY IMPLANTED. Manufacturer Narrative: THIS REPORT 1822565-2014- 01622 PERSONA PS ARTICULAR SURFACE 11/19/14 10/20/14 Malfunction WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01626 PERSONA POSTERIOR REFERENCING SIZER 11/19/14 Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETED Event Description: IT IS REPORTED THAT A WEAK DETENT ON THE SIZER IS CAUSING ROTATION OF THE SIZING BOOM DURING THE FEMORAL SIZING 9/29/14 Malfunction STEP OF THE PROCEDURE. 1822565-2014- 01611 PERSONA TIBIAL ARTICULAR SURFACE INSERTER 11/18/14 Event Description: IT IS REPORTED THAT THE HOOK ON THE ARTICULAR SURFACE INSERTER WAS DISCOVERED BROKEN OFF OF 10/7/14 Malfunction THE INSTRUMENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AND NUMBNESS ON LEG. THE PATIENT IS ALSO REPORTEDLY EXPERIENCING BREAKOUTS; RASH AND WATER BLISTERS ON FACE. PATIENT HAS REPORTEDLY BEEN DIAGNOSED WITH A SEVER NICKEL ALLERGY. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01604 UNKNONW PERSONA KNEE 11/14/14 Injury 1822565-2014- 01598 PERSONA VIVACIT- E PS ARTICULAR SURFACE 11/14/14 10/1/14 Injury Event Description: IT IS REPORTED THAT AN INCOMPATIBLE ARTICULAR SURFACE AND FEMORAL COMPONENT WERE IMPLANTED. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01597 PERSONA VIVACIT- E PS ARTICULAR SURFACE 11/14/14 9/29/14 Injury REPORTED THAT AN INCOMPATIBLE ARTICULAR SURFACE AND FEMORAL COMPONENT WERE IMPLANTED. 1822565-2014- 01577 PERSONA PEGGED POROUS TIBIAL COMPONENT 11/13/14 Injury THIS PATIENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01562 PERSONA PEGGED POROUS TIBIAL COMPONENT 11/13/14 Injury Event Description: IT IS REPORTED THAT THE SURGEON IS CONCERNED ABOUT RADIOLUCENCY OBSERVED ON ONE YEAR POST- OP X- RAYS. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE SHIM FOUND TO BE MISSING BOTH BEARINGS AFTER THE CLEANING PROCESS. THE BEARINGS WERE FOUND IN THE SONIC CLEANER. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR 1822565-2014- 01572 PERSONA ARTICULAR SURFACE PROVISONAL SHIM 11/12/14 10/13/14 Malfunction INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO A PATELLA TRACKING ISSUE. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A.: REVIEW OF THE PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. REVISION OPERATIVE NOTES INDICATE THE PT WAS REVISED DUE TO RECURRENT SUBLUXATION OF THE PATELLA. THE POSSIBILITY OF SOME INTERNAL ROTATION OF THE FEMUR WAS NOTED. ALL COMPONENTS WERE REVISED EXCEPT THE PATELLAR COMPONENT. NO FURTHER DESCRIPTION OF THE EXPLANTS WAS PROVIDED. REVIEW OF THE RETURNED RADIOGRAPHS CONFIRMS SUBLUXATION OF THE PATELLA. THE MEDIAL/LATERAL RADIOGRAPH DATED ON (B)(6) 2013 SUGGESTS INTERNAL ROTATION OF THE FEMORAL COMPONENT WITH RESPECT TO THE TIBIAL COMPONENT. INTERNAL ROTATION OF THE FEMORAL COMPONENT MAY CONTRIBUTE TO PATELLAR SUBLUXATION; HOWEVER; THIS CANNOT BE DEFINITIVELY CONFIRMED. THE PACKAGE INSERT PROVIDED WITH THE PATELLAR COMPONENT LISTS DISLOCATION AND/OR JOINT INSTABILITY AS AN ADVERSE EFFECT. THIS IS THEREFORE A KNOWN INHERENT RISK OF THE PROCEDURE. CAUSE CANNOT BE DEFINITIVELY DETERMINED.: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. THE INFO PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MFG REPORT NUMBER # 1822565-2014- 01559 PERSONA FEMORAL COMPONENT 11/12/14 9/17/14 Injury 2648920-2014- 00272. 1822565-2014- 01568 PERSONA STEMMED CEMENTED TIBIAL COMPONENT 11/12/14 10/13/14 Injury Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND LOOSENING. 1822565-2014- 01569 UNKNOWN PERSONA TIBIAL COMPONENT 11/12/14 Injury THIS PATIENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01575 PERSONA PEGGED POROUS TIBIAL COMPONENT 11/12/14 Injury THIS PATIENT. Manufacturer Narrative: INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01574 PERSONA PEGGED POROUS TIBIAL COMPONENT 11/12/14 Injury Event Description: IT IS REPORTED THAT THE SURGEON HAS OBSERVED RADIOLUCENCY ON ONE POST OP X- RAYS FOR THIS PT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01576 PERSONA PEGGED POROUS TIBIAL PLATE 11/12/14 Injury REPORTED THAT THE SURGEON HAS OBSERVED RADIOLUCENCY ON ONE POST OP X- RAYS FOR THIS PT. 1822565-2014- 01573 PERSONA PEGGED POROUS TIBIAL COMPONENT 11/12/14 Injury THIS PATIENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01570 UNKNOWN PERSONA TIBIAL COMPONENT 11/12/14 Injury REPORTED THAT THE SURGEON HAS OBSERVED RADIOLUCENCY ON ONE YEAR POST- OP X- RAYS FOR THIS PATIENT. Event Description: IT IS REPORTED THAT THE SHIM IS MISSING A BALL BEARING AND THE SPRING. Manufacturer Narrative: THIS 1822565-2014- 01534 PERSONAL ARTICULAR SURFACE PROVISIONAL SHIM 11/7/14 10/6/14 Malfunction REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01549 PERSONA TIBIAL ARTICULAR SURFACE SHIM 11/7/14 Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACE SHIM WAS MISSING THE BALL BEARING AFTER CLEANING. 10/9/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT DURING IMPLANTATION; THE FEMORAL COMPONENT SAT PROUD DISTALLY. 3007963827-2014- 00058 PERSONA CR CEMENTED STANDARD FEMUR 11/6/14 10/7/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01524 PERSONA TIBIAL ARTICULAR SURFACE SHIM 10/31/14 10/1/14 Malfunction REPORTED THAT THE SHIMS ARE MISSING BALL BEARINGS AND SPRINGS.
1822565-2014- 01518 UNKNOWN PERSONA TIBIA COMPONENT 10/31/14 Injury Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING A SUBSIDED TIBIA. THE PATIENT IS SCHEDULED FOR A REVISION SURGERY. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE MEASURING GUIDES DO NOT ACCURATELY MEASURE FEMORAL SIZE. 1822565-2014- 01513 PERSONA A- REF A/P SIZING GUIDE 10/30/14 9/29/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 2648920-2014- 00284 PERSONA PS ARTICULAR SURFACE 10/24/14 9/16/14 Malfunction REPORTED THAT THE ARTICULAR SURFACE WOULD NOT SEAT PROPERLY IN THE TIBIAL TRAY. 1822565-2014- 01443 PERSONA TM TWO- PEGGED POROUS NATURAL TIBIA 10/24/14 9/19/14 Injury REPORTED THAT THE PT WAS REVISED DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT. Event Description: IT IS REPORTED THAT THE DEVICE FRACTURED DURING USE. THE FRACTURED TIP WAS IDENTIFIED IN THE BACK OF THE JOINT AND WAS REMOVED. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION 1822565-2014- 01428 PERSONAL TIBIAL ARTICULAR SURFACE INSERTER 10/22/14 9/15/14 Malfunction IS Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT. 2648920-2014- 00278 PERSONA STEMMED CEMENTED TIBIAL PLATE 10/22/14 9/23/14 Injury Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS OTHER DEVICE USED: CATALOG #42527900700; PERSONAL TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM; LOT #62338676. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE TRIAL ARTICULAR SURFACE 1822565-2014- 01414 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 10/17/14 9/19/14 Malfunction PROVISIONAL SHIMS WERE MISSING ONE OF THE BALL BEARINGS. 1822565-2014- 01415 UNKNOWN PERSONA TASP SHIM INSTRUMENT 10/17/14 Event Description: IT IS REPORTED THAT THE BALL BEARINGS WERE FOUND IN THE ULTRA SONIC WASH SEPARATED FROM THE TRIAL ARTICULAR SURFACE PROVISIONAL SHIMS. Manufacturer Narrative: OTHER DEVICE USED: CATALOG #UNK; PERSONA TRIAL ARTICULAR SURFACE PROVISIONAL SHIM; LOT #UNK - QUANTITY 4. THIS REPORT WILL BE AMENDED WHEN OUR Malfunction INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING PATELLA TRACKING ISSUES. Manufacturer Narrative: THIS 1822565-2014- 01403 UNK PERSONA PATELLA 10/16/14 Injury REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01401 UNK PERSONA PATELLA 10/16/14 Injury Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO PATELLA TRACKING ISSUES. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01402 UNK PERSONA PATELLA 10/16/14 Injury Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING PATELLA TRACKING ISSUES. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01404 UNK PERSONA PATELLA 10/16/14 Injury Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING PATELLA TRACKING ISSUES. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 2648920-2014- 00272 PERSONA ALL POLY PATELLA 10/16/14 9/17/14 Injury Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO PATELLA TRACKING ISSUES. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01405 UNK PERSONA PATELLA 10/16/14 Injury Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING PATELLA TRACKING ISSUES. Manufacturer Narrative: INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 2648920-2014- 00268 PERSONA STEMMED TIBIAL COMPONENT 10/15/14 9/15/14 Injury Event Description: IT IS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION AND THE FIRST STAGE OF A TWO STAGE REVISION FOR LOOSENING; INSTABILITY; AND INFECTION SUSPECTED BY THE SURGEON. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01365 UNK PERSONA TM TIBIAL PLATE 10/10/14 Injury Event Description: IT IS REPORTED THAT X- RAYS SHOW POSSIBLE RADIOLUCENCY BETWEEN THE TIBIAL PLATE AND THE BONE FOR AN UNK NUMBER OF PTS. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01356 PERSONA TM TWO- LEG NATURAL POROUS TIBIA 10/10/14 Injury Event Description: IT IS REPORTED THAT THE TM TIBIA WAS IMPLANTED AND HAS BECOME LOOSE. A REVISION SURGERY IS PENDING. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01369 UNK PERSONA TM TIBIAL COMPONENT 10/10/14 Injury Event Description: IT IS REPORTED THAT X- RAYS SHOW POSSIBLE RADIOLUCENCY BELOW THE TIBIAL PLATE. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01336 PERSONA TIBIA ARTICULAR SURFACE PROVISIONAL 10/9/14 Malfunction REPORTED THAT THE SHIM IS MISSING ONE OF THE BALL BEARINGS. 1822565-2014- 01302 PERSONA TIBIAL ARTICULAR SURFACE INSERTER 10/7/14 9/10/14 Malfunction REPORTED THAT WHILE INSERTING A PERSONAL POLY; THE TIP OF THE ARTICULAR SURFACE INSERTER SNAPPED OFF. 1822565-2014- 01299 PERSONA TIBIAL ARTICULAR SURFACE SHIM 10/7/14 Event Description: IT IS REPORTED DURING THE CLEANING AND STERILIZATION PROCESS THAT THE BALL BEARINGS WERE FALLING OUT AND DISCOVERED MISSING FROM THE PROVISIONAL TEMPLATES. Manufacturer Narrative: THIS REPORT WILL BE 8/6/14 Malfunction AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01294 PERSONA POSTERIOR REFERENCING SIZER 10/2/14 Event Description: IT IS REPORTED THAT THE SPRING DETENT THAT INTERFACES WITH THE BOOM DOES NOT HOLD THE BOOM SOLIDLY IN PLACE ENOUGH DURING THE SIZING PORTION OF THE SURGERY. THE SURGEON FEELS THAT THE SOFT TISSUE PRESSURE CAUSES THE PERSONA POSTERIOR REFERENCING SIZER BOOM TO ROTATE CAUSING THE USER TO READ A SMALLER SIZE THAN THE FEMUR ACTUALLY IS. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Malfunction Event Description: IT IS REPORTED THAT THE PT WAS IMPLANTED WITH A PERSONA KNEE SYSTEM IN (B)(6) 2013 AND IS SCHEDULED FOR A REVISION SURGERY IN (B)(6) 2014 FOR UNK REASONS. Manufacturer Narrative: THIS REPORT WILL BE 1822565-2014- 01234 UNK PERSONA ARTICULAR SURFACE 9/26/14 Injury AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT DURING AN INSERVICE AT A HOSP; THE BALL BUSHING FELL OUT OF THE TOWER. NO 1822565-2014- 01166 PERSONA ADJUSTABLE RESECTION TOWER 9/19/14 8/20/14 Malfunction PT WAS INVOLVED. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUT INVESTIGATION IS 3007963827-2014- 00043 PERSONA CR FEMORAL COMPONENT 9/17/14 8/19/14 Injury Event Description: IT IS REPORTED THAT THE PATIENT WAS NOT ACHIEVING FLEXION GOALS AND UNDERWENT MANIPULATION UNDER ANESTHESIA. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE HOOK ON THE POLY INSERTER BROKE OFF AND COULD NOT BE LOCATED. IT WAS CONFIRMED VIA X- RAY THAT THE FRAGMENT WAS NOT RETAINED IN THE PATIENT. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED 1822565-2014- 01113 PERSONA TIBIAL ARTICULAR SURFACE INSERTER 9/11/14 8/7/14 Malfunction WHEN OUR INVESTIGATION IS 1822565-2014- 01095 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 9/10/14 Event Description: IT IS REPORTED THAT THE SHIMS ARE MISSING BOTH BALL BEARINGS. Manufacturer Narrative: THIS REPORT 8/14/14 Malfunction WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01102 UNK TRABECULAR METAL PERSONA TIBIA 9/10/14 Event Description: IT IS REPORTED THAT INITIAL X- RAYS SHOWED RADIOLUCENCY AT THE MARGINS OF THE TIBIAL COMPONENT. THE PT IS REPORTEDLY ASYMPTOMATIC. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR Malfunction INVESTIGATION IS 1822565-2014- 01094 UNK TRABECULAR METAL PERSONA TIBIA 9/10/14 Event Description: IT IS REPORTED THAT INITIAL X- RAYS SHOWED RADIOLUCENCY AT THE MARGINS OF THE TIBIAL COMPONENT. THE PT IS REPORTEDLY ASYMPTOMATIC. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR Malfunction INVESTIGATION IS 2648920-2014- 00239 PERSONA STEMMED CEMENTED TIBIAL PLATE 9/9/14 REPORTED THAT THE LOCKING SCREW ON THE TIBIA KEEL WAS NOT TIGHTENED; WHICH CAUSED THE STEM EXTENSION TO 8/7/14 Malfunction LOOSEN DURING IMPACTION. 1822565-2014- 01070 PERSONA TIBIAL ARTICULAR SURFACE SHIM 9/4/14 Event Description: IT IS REPORTED THAT THE SHIM IS MISSING ONE OF THE BALL BEARINGS. Manufacturer Narrative: THIS 8/6/14 Malfunction REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING. Manufacturer Narrative: 2648920-2014- 00227 PERSONA CEMENTED STEMMED TIBIAL COMPONENT 9/3/14 7/31/14 Injury THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A LEFT FEMORAL COMPONENT INTO THE RIGHT 3007963827-2014- 00042 PERSONA PS CEMENTED FEMORAL COMPONENT 8/29/14 7/14/14 Injury KNEE. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT ES EXPERIENCING LOOSENING. Manufacturer Narrative: EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X- RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO HOWEVER; NO FURTHER INFO HAS BEEN RECEIVED TO DATE. EVAL CODES: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE 1822565-2014- 01044 UNK PERSONA TIBIAL COMPONENT 8/28/14 Injury RECEIVED; THE COMPLAINT WILL BE REOPENED. ZIMMER; INC CONSIDERS THE INVESTIGATION CLOSED. Event Description: IT IS REPORTED THAT THE TIP OF THE INSTRUMENT BROKE. Manufacturer Narrative: THIS REPORT WILL BE 1822565-2014- 01027 PERSONA TIBIAL ARTICULAR SURFACE INSERTER 8/26/14 6/19/14 Malfunction AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 01008 PERSONA TIBIAL ARTICULAR SURFACE INSERTER 8/21/14 Event Description: IT IS REPORTED THAT WHILE INSERTING POLY; THE TIP BROKE OFF THE ARTICULAR SURFACE INSERTER. 7/21/14 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00978 PERSONA ARTICULAR SURFACE SHIM 8/13/14 Event Description: IT IS REPORTED THAT BOTH BALL BEARINGS WERE MISSING FORM THE PROVISIONAL SHIM. Manufacturer Malfunction Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT. Manufacturer Narrative: INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL 1822565-2014- 00979 PERSONA STEMMED CEMENTED TIBIAL PLATE 8/13/14 7/15/14 Injury BE AMENDED WHEN OUT INVESTIGATION IS
Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT WAS 2648920-2014- 00193 PERSONA ARTICULAR SURFACE 7/31/14 6/26/14 Malfunction REPORTED THAT THE ARTICULAR SURFACE WOULD NOT SEAT ON THE LATERAL SIDE. Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO TIBIAL SUBSIDENCE. Manufacturer Narrative: THIS 2648920-2014- 00192 UNK PERSONA TIBIAL COMPONENT 7/31/14 Injury REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE SHIMS ARE MISSING ONE OR BOTH BALL BEARINGS. Manufacturer Narrative: INFO WAS REC'D FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED 1822565-2014- 00916 PERSONA TIBIA ART SURFACE PROVISIONAL SHIM 7/30/14 6/20/14 Malfunction WHEN OUR INVESTIGATION IS 2648920-2014- 00187 PERSONA STEMMED NATURAL TIBIA CEMENTED 7/24/14 Event Description: IT IS REPORTED THAT THE STEMMED TIBIAL WAS OPENED AND THE PLASTIC TAPER PLUG WOULD NOT STAY SEATED IN THE STEM. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS EVALUATION SUMMARY: UPON INITIAL REVIEW; THE POLY PLUG WOULD NOT STAY IN PLACE IN THE TAPER; LESS THAN 1/4 TURN ON THE SET SCREW CAPTURED AND LOCKED THE POLY PLUG IN IT'S INTENDED LOCATION. A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. EVALUATION CODES: DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. DIMENSIONS WERE FOUND TO MEET PRINT SPECIFICATION WHERE MEASURED. VISUAL EXAMINATION REVEALED CURED BONE CEMENT ON THE UNDERSIDE OF THE TIBIAL BASEPLATE. THE POLYETHYLENE TAPER PLUG WAS 6/9/14 Malfunction INITIALLY DISENGAGED FROM THE TIBIAL BASEPLATE. 1822565-2014- 00898 PERSONA TIBIA ARTICULAR SURFACE PROVISIONAL 7/20/14 REPORTED THAT PRIOR TO INCISION; THE SCRUB TECH WAS DOING THE INITIAL SET UP AND NOTICED THE TWO BALL BEARINGS 6/11/14 Malfunction WERE MISSING IN THE SHIM AND WAS NOT ABLE TO BE USED. ANOTHER SHIM WAS USED TO COMPLETE THE SURGERY. 1822565-2014- 00899 PERSONA TIBIA ARTICULAR SURFACE PROVISIONAL 7/20/14 Event Description: IT IS REPORTED THAT THE DAY AFTER SURGERY; DURING CLEANING; THAT THE BALL BEARINGS WERE 6/16/14 Malfunction MISSING. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00851 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 7/11/14 REPORTED THAT DURING SURGERY THE SURGEON NOTED THAT A BALL BEARING WAS MISSING FROM THE INSTRUMENT. IT Malfunction COULD NOT BE DETERMINED WHEN IT WAS LOST. 1822565-2014- 00852 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 7/11/14 Event Description: IT IS REPORTED THAT THE PROVISIONAL SHIM IS MISSING ONE OF THE BALL BEARINGS. Manufacturer Malfunction Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00842 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 7/11/14 Event Description: IT IS REPORTED THAT DURING KIT INSPECTION IT WAS NOTED THAT SPRINGS AND BALLS WERE MISSING Malfunction FROM THE SHIMS. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING LOOSENING. Manufacturer Narrative: THIS REPORT WILL BE 1822565-2014- 00854 UNK PERSONA TIBIA COMPONENT 7/11/14 Injury AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00848 UNK PERSONAL TIBIAL COMPONENT 7/11/14 Injury Event Description: IT IS REPORTED THAT THE PT IS BEING FOLLOWED FOR LOOSENING. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00855 UNKNOWN PERSONA TIBIA COMPONENT 7/11/14 Injury Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING LOOSENING. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00849 UNKNOWN PERSONA TIBIAL COMPONENT 7/11/14 Injury Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING LOOSENING. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00834 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 7/10/14 Malfunction REPORTED THAT DURING KIT INSPECTION IT WAS NOTED THAT A BALL BEARING WAS MISSING FROM THE SHIM. 2648920-2014- 00167 PERSONA ALL POLY PATELLA 7/9/14 Event Description: IT IS REPORTED THAT DEBRIS WAS DISCOVERED INSIDE THE PATELLA PACKAGING DURING SURGERY. A SECOND PATELLA WAS OPENED AND USED INSTEAD. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR 5/22/14 Malfunction INVESTIGATION IS 1822565-2014- 00819 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 7/8/14 REPORTED THAT DURING KIT INSPECTION IT WAS DISCOVERED THAT ONE OF THE BALL BEARINGS WAS MISSING FROM THE Malfunction SHIM. Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN; IRRITATION; FATIGUE AND POSSIBLE LOCKING FROM THE KNEE COMPONENT. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. OTHER DEVICE USED: CATALOG #42532007902; PERSONA CEMENTED STEMMED TIBIAL COMPONENT; LOT #62268946 - MANUFACTURED BY ZIMMER (B)(4). CATALOG #42522401011; PERSONAL VIVACITE ARTICULAR SURFACE; LOT #62262829 - (B)(4). CATALOG #42540200038; PERSONA ALL POLY PATELLA; LOT #62256306 - MANUFACTURED BY ZIMMER (B)(4). THE INFORMATION PROVIDED ON THIS FORM WAS PREVIOUSLY SUBMITTED UNDER MANUFACTURING REPORT 3007963827-2014- 00028 PERSONA PS CEMENTED FEMORAL COMPONENT 7/8/14 Injury NUMBER 1822565-2014- 00651. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT PT WAS REVISED DUE TO LOOSENING. Manufacturer Narrative: THIS REPORT WILL BE 1822565-2014- 00800 PERSONA TM TWO PEG TIBIAL COMPONENT 7/1/14 5/12/14 Injury AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00792 UNK PERSONA FEMORAL COMPONENT 6/30/14 Injury Event Description: IT IS REPORTED THAT A REVISION SURGERY IS PENDING FOR UNK REASONS. Manufacturer Narrative: EVAL SUMMARY: COMPATIBILITY COULD NOT BE VERIFIED. SURGICAL NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. HOWEVER; THE COMPLAINT MAY BE REVISED UPON RETURN OF RADIOGRAPHS AND/OR PRODUCT OR FURTHER INFO. EVAL CODES: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO; HOWEVER; NO INFO HAS BEEN RECEIVED TO DATE. 1822565-2014- 00749 UNK PERSONA VIVACIT- E ARTICULAR SURFACE 6/13/14 11/20/13 Injury Event Description: IT IS REPORTED THAT THE PT UNDERWENT AN ARTICULAR SURFACE EXCHANGE FOR UNK REASONS. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE DISC FRACTURED FROM IMPACTOR DURING SURGERY. X- RAYS WERE TAKEN AND IT WAS DETERMINED THAT NO PIECE REMAINED IN THE PT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN 1822565-2014- 00744 PERSONA CEMENTED TIBIAL BROACH INSERTER 6/12/14 5/13/14 Malfunction OUR INVESTIGATION IS 1822565-2014- 00745 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 6/12/14 Event Description: IT WAS DISCOVERED DURING KIT INSPECTION THAT THE BALL BEARINGS ARE MISSING FROM THE ARTICULAR Malfunction SURFACE PROVISIONAL. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00735 PERSONA ARTICULAR SURFACE PROVISIONAL SHIM 6/11/14 Event Description: IT WAS DISCOVERED DURING SURGERY THAT THE BALL BEARINGS WERE MISSING FROM THE ARTICULAR Malfunction SURFACE PROVISIONAL. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00707 PERSONA ARTICULAR SURFACE PROVISIONAL 6/6/14 Event Description: IT IS REPORTED THAT A BALL BEARING WAS MISSING FROM THE PROVISIONAL. THIS WAS DISCOVERED BY THE REPRESENTATIVE AND TECHNICIAN DURING THE SET UP FOR THE CASE. Manufacturer Narrative: THIS REPORT WILL BE 4/25/14 Malfunction AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO TIBIAL LOOSENING. Manufacturer Narrative: THIS 1822565-2014- 00680 UNK PERSONA TIBIA 5/30/14 4/30/14 Injury REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00651 UNK PERSONA KNEE 5/22/14 Injury Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING PAIN; IRRITATION; FATIGUE AND POSSIBLE LOCKING FROM THE KNEE COMPONENT. Manufacturer Narrative: EVALUATION SUMMARY: PRIMARY OPERATIVE NOTES INDICATE THAT FULL EXTENSION AND 135 DEGREES OF FLEXION WITH VARUS AND VALGUS STABILITY WAS ACHIEVED. REVIEW OF THE PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. REVIEW OF THE OFFICE VISIT NOTES DOES NOT INDICATE ROOT CAUSE. REVIEW OF THE RETURNED RADIOGRAPHS DOES NOT INDICATE ROOT CAUSE. THE IMPLANTS APPEAR TO BE IN PROPER POSITION AND WELL ALIGNED. NO DEVICES OR PHOTOS WERE RECEIVED AS THE COMPONENTS ARE STILL IMPLANTED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. PART AND LOT NUMBERS ARE UNK; THEREFORE; DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AND COMPATIBILITY COULD NOT BE VERIFIED. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. 1822565-2014- 00644 PERSONA ALTA VE ARTICULAR SURFACE 5/21/14 4/21/14 Injury Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO INSTABILITY. Manufacturer Narrative: EVAL SUMMARY - COMPATIBILITY WAS VERIFIED WITH NO ISSUES NOTED. AN EMAIL CORRESPONDENCE WITH THE SALES ASSOCIATE INDICATED THAT THE PT'S FEMORAL COMPONENT WOULD DISLOCATE OVER THE CENTER OF THE ARTICULAR SURFACE. THIS SUBLUXATION THEN LED TO THE DISLOCATION OF THE PATELLA. THE ARTICULAR SURFACE WAS REPLACED WITH AN 18MM HEIGHT AND STABILITY WAS OBTAINED. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE; THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. HOWEVER; THE COMPLAINT MAY BE REVISED UPON RETURN OF RADIOGRAPHS AND/OR PRODUCT OR FURTHER INFO. DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFIRMING. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.
1822565-2014- 00633 UNKNOWN PERSONA TIBIA 5/20/14 Injury Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING TIBIAL LOOSENING. THERE IS A PLANNED REVISION FOR (B)(6) 2014. Manufacturer Narrative: EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. RADIOGRAPHS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED; THE COMPLAINT WILL BE REOPENED. ZIMMER; INC. CONSIDERS THE INVESTIGATION CLOSED. Event Description: IT IS REPORTED THAT THE PROVISIONAL IS MISSING A BALL BEARING. Manufacturer Narrative: EVALUATION SUMMARY: IT WAS EVIDENT THAT THE HOLE THAT CONTAINED THE COMPONENTS HAD GONE THROUGH THE SWAGING PROCESS. THE SWAGING PROCESS IS VALIDATED PER THE SUPPLIER TO PRODUCE A CONFORMING SWAGED HOLE DIAMETER. THE CAUSE OF THE MISSING COMPONENT IS UNK. EVAL: VISUAL EXAMINATION IDENTIFIED MISSING SUB- COMPONENTS FROM 1822565-2014- 00616 PERSONA TIBAL ARTICULAR SURFACE PROVISIONAL 5/14/14 Malfunction THE SWAGED HOLE. Manufacturer Narrative: COMPATIBILITY WAS VERIFIED WITH NO ISSUES NOTED. THE PATTERN OF WEAR SUGGESTS IMPROPER ALIGNMENT. RADIOGRAPHS WERE NOT RETURNED FOR REVIEW; THEREFORE; ALIGNMENT CANNOT BE VERIFIED. CAUSE CANNOT BE DEFINITIVELY DETERMINED WITH THE INFORMATION PROVIDED. DEVICE HISTORY RECORDS WERE REVEILED AND FOUND TO BE CONFORMING. VISUAL EXAMINATION OF THE RETURNED ARTICULAR SURFACE REVEALED WEAR DAMAGE TO THE POSTERIOR ASPECT OF THE MEDIAL CONDYLE ON THE ARTICULATING SURFACE. THERE IS ALSO WEAR DAMAGE ON THE POSTEROLATERAL EDGE NEAR THE SUPERIOR SURFACE OF THE POSTERIOR STABILIZING SPINE. NO OTHER DAMAGE WAS IDENTIFIED. Event Description: IT IS REPORTED THAT THE PT UNDERWENT AN IRRIGATION AND DEBRIDEMENT. DURING THE 1822565-2014- 00626 PERSONA VIVACIT- E PS ARTICULAR SURFACE 5/14/14 3/4/14 Injury PROCEDURE; THE SURGEON NOTICED A WEAR PATTERN AND ELECTED TO PERFORM AN ARTICULAR SURFACE EXCHANGE. Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACE DID NOT LOCK SECURELY ON TO THE TIBIAL PLATE. Manufacturer Narrative: EVAL SUMMARY: IT IS LIKELY THAT THE PROBLEMS ENCOUNTERED ARE RELATED TO SURGICAL TECHNIQUE. NO OTHER COMPLAINT OF THIS NATURE HAVE BEEN RECEIVED FOR THIS PRODUCT/LOT COMBINATION AND NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED FROM THIS SURGEON. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND CONFORMING. DIMENSION MEASURE FOUND THE PART TO BE CONFORMING TO PRINT SPECS. VISUAL EXAMINATION IDENTIFIED THAT THE DOVETAIL FEATURE WAS COMPRESSED DOWN BOTH SIDES; INDICATING THAT THE ARTICULAR SURFACE WAS NOT CORRECTLY PLACED AND ORIENTED BEFORE PUSHING IT USING THE INSERTER INSTRUMENT. IT 1822565-2014- 00549 PERSONA HIGHLY CROSSLINKED ARTICULARSURFACE 5/1/14 3/26/14 Malfunction WAS ALSO NOTED THAT THERE IS GOUGING TO THE UNDERSIDE OF THE ARTICULAR SURFACE; LIKELY DUE TO REMOVAL. 1822565-2014- 00527 PERSONA VIVACIT- E PS ARTICULAR SURFACE 4/24/14 Event Description: IT IS REPORTED THAT THE SURGEON WAS UNABLE TO PROPERLY INSERT THE ARTICULAR SURFACE. AFTER SEVERAL ATTEMPTS AN ADDITIONAL SURFACE OF THE SAME SIZE WAS OPENED AND EASILY INSERTED. Manufacturer Narrative: 3/29/14 Malfunction THIS REPORT WILL BE AMENDED WHEN OUT INVESTIGATION IS 2648920-2014- 00069 PERSONA CEMENTED NATURAL TIBIA 4/2/14 Event Description: IT IS REPORTED THAT THE TIBIAL COMPONENT APPEARED TO BE SMALLER THAN THE "G" LABELED ON THE BOX. THE 10 MM POLY WOULD NOT LOCK INTO THE TRAY. THE SURGEON WAS FINALLY ABLE TO GET THE 11 MM POLY MOST OF THE WAY DOWN. Manufacturer Narrative: A PICTURE OF AN AP RADIOGRAPH WAS RECEIVED; HOWEVER; DIMENSIONAL ANALYSIS WAS INCONCLUSIVE DUE TO THE POOR QUALITY OF THE PHOTOGRAPH. IT IS LIKELY THAT THE PROBLEMS ENCOUNTERED ARE RELATED TO SURGICAL TECHNIQUE. DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. VISUAL EXAMINATION OF THE RETURNED ARTICULAR SURFACE CONFIRMS THE CENTRAL ASPECT OF THE LOCKING DOVETAIL IS COMPRESSED; THE TRACKS ON THE INTERNAL ASPECT ARE SEVERELY DEFORMED; THE TRACKS ON THE EXTERNAL ASPECT ARE ONLY SIGNIFICANTLY DAMAGED ON THE MEDIAL SIDE; AND THERE IS SIGNIFICANT DAMAGE TO THE ANTERIOR ASPECT OF THE ARTICULAR SURFACE CONSISTENT WITH ATTEMPTS TO IMPACT THE COMPONENT. IN THE CASE WHERE THE TIBIAL COMPONENT WAS A SMALLER SIZE; IT WOULD BE EXPECTED THAT BOTH SIDES OF THE EXTERNAL DOVETAIL TRACK WOULD BE DAMAGED ON THE POSTERIOR ASPECT. THE DAMAGE TO THE DOVETAIL TRACKS IS INDICATIVE OF IMPROPER 3/4/14 Malfunction ALIGNMENT DURING INSERTION. Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN. THE PATIENT IS ALSO REPORTED A POSSIBLE INFECTION AND HAS NEVER FELT THE INCISION HEALED. Manufacturer Narrative: PRIMARY OPERATIVE NOTES STATE THE KNEE CAME TO FULL FLEXION AND EXTENSION WITH STABILITY AT MID FLEXION. INTRAOPERATIVE AND POSTOPERATIVE RADIOGRAPHS DO NOT INDICATE ROOT CAUSE. ANALYSIS PERFORMED BY THE INTERPRETING PHYSICIAN REPORTS SATISFACTORY POSITIONING OF THE IMPLANTS AND POSTOPERATIVE SWELLING. SINGLE- USE; STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE; IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. BASED ON THE AVAILABLE INFO; A DEFINITIVE CAUSE CANNOT BE DETERMINED. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY 2648920-2014- 00068 PERSONA FIXED BEARING PS ARTICULAR SURFACE 4/2/14 Injury EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. 2648920-2014- 00073 PERSONA CR ARTICULAR SURFACE 4/2/14 3/4/14 Injury Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND A GRINDING NOISE. Manufacturer Narrative: EVALUATION SUMMARY: RADIOGRAPHS WERE NOT PROVIDED; THEREFORE; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. COMPATIBILITY COULD NOT BE VERIFIED. OPERATIVE NOTES WERE NOT RETURNED. BASED ON THE AVAILABLE INFO; A DEFINITIVE ROOT CAUSE CANNOT BE ASCERTAINED AT THIS TIME. EVALUATION CODES: VISUAL EXAMINATION IDENTIFIED LINEAR PITTING AND GOUGING ON THE SUPERIOR SURFACE. THE GOUGING VISUALIZED IS IN A LINEAR PATTERN; TRANSLATING IN THE ANTERIOR/POSTERIOR DIRECTION. THE DAMAGE SUGGESTS THAT DEBRIS WAS PRESENT IN THE JOINT. IT IS UNKNOWN HOW THE DEBRIS WAS INTRODUCED INTO THE JOINT. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. Event Description: IT IS REPORTED THAT DURING PREPARATION OF THE TIBIA; THE DRILL PERFORATED THE ANTERIOR CORTEX OF THE TIBIA. THE SURGEON DESCRIBED THE TIBIA AS HAVING A UNIQUE MORPHOLOGY AND PLACING SLIGHTLY MORE SLOPE 1822565-2014- 00395 PERSONA TIBIAL DRILL BIT 3/26/14 2/13/14 Malfunction ON THE TIBIA. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS REPORTED THAT THE SALES REP HAS HEARD OF MULTIPLE PATIENTS COMPLAINING ABOUT A CLICK NOISE WITH THE PERSONA 1822565-2014- 00254 UNKNOWN ZIMME PERSONA PS KNEE 3/6/14 Injury PS COMING OUT OF DEEP FLEXION. 1822565-2014- 00197 PERSONA STEMMED TIBIAL COMPONENT 2/19/14 Injury Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN; LACK OF MOBILITY; AND FEELS THAT THE IMPLANT IS LOOSE. Manufacturer Narrative: EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X- RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED; THE COMPLAINT WILL BE REOPENED. ZIMMER; INC. CONSIDERS THE INVESTIGATION CLOSED. Event Description: IT IS REPORTED THAT THE ARTICULAR SURFACE WAS INSERTED INTO THE APPROPRIATE SIZED KNEE COMPONENTS AND WOULD NOT SIT DOWN INTO THE TIBIAL WAY. Manufacturer Narrative: THIS REPORT WILL BE AMENDED 1822565-2014- 00184 PERSONA VIVACIT- E PS ARTICULAR SURFACE 2/13/14 1/14/14 Malfunction WHEN OUR INVESTIGATION IS 2648920-2014- 00011 PERSONA STEM TIBIA 1/29/14 Event Description: IT IS REPORTED THAT THE POLY PIECE ATTACHED TO THE BASE OF THE TIBIAL IMPLANT WAS LOOSE AND WOULD NOT STAY ATTACHED TO THE IMPLANT. APPLIED CEMENT TO THE OUTER DIAMETER OF THE POLY AND CEMENTED IT TO THE IMPLANT. Manufacturer Narrative: THIS INFO WAS PREVIOUSLY REPORTED UNDER 1822565-2013- 01332. EVALUATION: AN X- RAY RECEIVED OF THE IMPLANTED DEVICE SUGGESTED THE SET SCREW FOR THE POLY PLUG IS MISSING. INVESTIGATION FOUND THE CURRENT ROUTER REQUIRES ASSEMBLY OF THE PLOY SUBCOMPONENTS; AND THE INSPECTION CRITERION REQUIRES VERIFICATION OF ASSEMBLY. RISK ASSESSMENT CONCLUDED THE SET SCREW HAS TWO PURPOSES: SECURING THE TAPER PLUG IN PLACE WHEN THE TIBIAL COMPONENT IS CEMENTED INTO PLACE AND AS A SECONDARY LOCKING MECHANISM FOR STEM EXTENSIONS. IT WAS DETERMINED A SET SCREW COULD BE OBTAINED FROM ADD'L UNITS OF THIS PRODUCT LINE; REGARDLESS OF SIZE; OR FROM NEXGEN LCCK; CRA AND RHK FEMORAL COMPONENTS; AS THE SAME SET SCREW IS USED WITH THESE UNITS. ONLY ONE ADD'L REPORT FROM THIS LOT HAS BEEN RECEIVED; THIS EVENT WAS REPORTED UNDER MDR #2648920-2013- 00146. ROOT CAUSE FOR THIS EVENT APPEARS TO BE NONCONFORMANCE TO WORK INSTRUCTIONS; CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO PREVENT FUTURE OCCURRENCE. AVAILABLE STOCK WAS EVALUATED; FINDING THAT 4 OF 8 ADD'L UNITS WERE ALSO MISSING THE SET SCREW. SHOULD ADD'L SUBSTANTIVE INFO BE 7/12/13 Malfunction RECEIVED; THE COMPLAINT WILL BE REOPENED. ZIMMER; INC. CONSIDERS THE INVESTIGATION CLOSED. Event Description: IT IS REPORTED THAT THE PT UNDERWENT MANIPULATION DUE TO STIFFNESS IN THE LEFT KNEE. 1822565-2014- 00107 PERSONA CR FEMORAL COMPONENT 1/22/14 12/23/13 Injury Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00092 PERSONA TM TWO PEG TIBIAL COMPONENT 1/16/14 12/17/13 Injury Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO TIBIAL SUBSIDENCE. DURING THE REVISION SURGERY; IT WAS DETERMINED THAT THE TIBIA WAS WELL FIXED; THAT THE TIBIAL COMPONENT WAS UNDERSIZED; AND THAT THERE WAS NO ANTERIOR RIM CAPTURE. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00049 PERSONA CR TRABECULAR METAL POROUS FEMUR 1/9/14 12/11/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LACK OF INGROWTH. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2014- 00050 PERSONA CR TRABECULAR METAL POROUS FEMUR 1/9/14 11/13/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND LACK OF INGROWTH. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS
Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING LOOSENING OF THE KNEE IMPLANT. Manufacturer 1822565-2013- 01879 UNKNOWN PERSONA TIBIA 12/23/13 Malfunction Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 01881 UNKNOWN PERSONA TIBIA 12/23/13 Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING LOOSENING OF THE KNEE IMPLANT. Manufacturer Malfunction Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 01871 UNKNOWN PERSONA TIBIA 12/23/13 Event Description: IT IS REPORTED THAT THE PATIENT IS EXPERIENCING LOOSENING OF THE KNEE IMPLANT. Manufacturer Malfunction Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT AND A PERIPROSTHETIC 3007963827-2013- 00046 PERSONA CCR FEMORAL COMPONENT 12/23/13 10/22/13 Injury FRACTURE. REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. THE SURGEON REVISED THE PATELLA DUE TO AN OBLIQUE CUT. THE 2648920-2013- 00263 PERSONA ARTICULAR SURFACE 12/19/13 10/7/13 Injury ARTICULAR SURFACE WAS NOTED TO HAVE ABNORMAL WEAR. 1822565-2013- 01797 PERSONA CR FEMORAL COMPONENT 12/17/13 11/5/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 01714 PERSONA FIXED BEARING PS ARTICULAR SURFACE 11/27/13 10/15/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO WEAR ON THE POLY. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 01716 PERSONA CR NARROW FEMORAL COMPONENT 11/26/13 Injury Event Description: IT IS REPORTED THAT THE PT IS EXPERIENCING NUMBNESS AND TINGLING IN HER LATERAL LOWER EXTREMITY. Manufacturer Narrative: EVAL SUMMARY: NO DEVICES OR PHOTOS WERE REC'D; THEREFORE THE CONDITION OF THE COMPONENTS IS UNK. SURGICAL NOTES WERE NOT PROVIDED. X- RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED; INDICATING THE DEVICES WERE MANUFACTURED; INSPECTED; AND PACKAGED TO SPECIFICATIONS. 1822565-2013- 01647 PERSONA POSTERIOR REFERENCING SIZER 11/14/13 Event Description: IT IS REPORTED THAT DURING MULTIPLE PROCEDURES USING THESE DEVICES WITH A SETTING USING 3 DEGREEA OF EXTERNAL ROTATION; THE JOINT HAS BEEN TIGHT IN FLEXION ONLY IN THE POSTERIOR MEDIAL RESULTING IN GRADUAL RELEASES OF PCL FIBERS UNTIL BALANCED WITH POSTERIOR LATERAL FLEXION. AS A RESULT; THE SURGEON HAS HAD TO CONVERT TO AN ULTRA CONGRUENT KNEE SYSTEM. Manufacturer Narrative: INFO WAS RECEIVED FROM A DISTRIBUTOR Malfunction WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 01643 PERSONA STEMMED TIBIAL COMPONENT 11/13/13 Event Description: IT IS REPORTED THAT THE IMPLANTS WERE ONLY PACKAGED WITH 1 OUT OF 2 PLASTIC STERILIZED BOXES. 10/14/13 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 01553 PERSONA STEMMED TIBIAL COMPONENT 10/25/13 Event Description: IT IS REPORTED THAT THERE ARE GROOVES ON THE PLATEAU OF THE IMPLANT IN THE POSTERIOR CORNERS. 8/6/13 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT DURING IMPACTION OF THE FEMORAL COMPONENT; THE FEMUR FRACTURED. 3007963827-2013- 00039 PERSONA PS CEMENTED FEMORAL COMPONENT 10/25/13 9/10/13 Injury Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE SURGEON HAD A PROBLEM INSERTING THE VIVACIT- E ARTICULAR SURFACE. AFTER SEVERAL ATTEMPTS AT INSERTING THE ARTICULAR SURFACE THE SURGEON DECIDED TO US A STANDARD ARTICULAR SURFACE INSTEAD TO COMPLETE THE SURGERY. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 01548 PERSONA VIVACIT- E 10/24/13 8/27/13 Malfunction COMPLETED. 2648920-2013- 00219 PERSONA NATURAL TIBIAL COMPONENT 10/17/13 Event Description: IT WAS REPORTED THAT WHILE IMPACTING AND CEMENTING THE FINAL TIBIAL PLATE IT BECAME OBVIOUS THAT THERE WAS STAINS ON THE POLISHED SURFACE OF THE TIBIA; WHERE THE IMPACT HAD TAKEN PLACE. Manufacturer Malfunction Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO PAIN FROM THE DISPLACEMENT OF THE LOCKING MECHANISM OF ARTICULAR SURFACE. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS 2648920-2013- 00220 PERSONA CR ARTICULAR SURFACE 10/17/13 10/1/13 Injury NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT DURING THE INSERTION OF THE ARTICULAR SURFACE; A THIN SPLICE OF METAL FRACTURED FROM THE TIBIAL PLATE. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 2648920-2013- 00197 PERSONA NATURAL STEMMED TIBIA 9/18/13 8/9/13 Malfunction 1822565-2013- 01332 PERSONA STEM TIBIA 9/12/13 Event Description: IT IS REPORTED THAT THE POLY PIECE ATTACHED TO THE BASE OF THE TIBIAL IMPLANT WAS LOOSE AND WOULD NOT STAY ATTACHED TO THE IMPLANT. APPLIED CEMENT TO THE OUTER DIAMETER OF THE POLY AND CEMENTED IT TO 7/12/13 Malfunction THE IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO MISMATCHED PRODUCT. Manufacturer Narrative: THIS 2648920-2013- 00196 PERSONA ARTICULAR SURFACE 9/12/13 8/16/13 Injury REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE DUE TO PAIN AND SUBLUXATION. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE IMPLANT SURGICAL NOTES INDICATE THAT THE PATIENT HAD A VARUS DEFORMITY WHICH REQUIRED DEEP RELEASE OF THE MCL. IT IS NOTED THAT THE TRIALS AND FINAL REDUCTIONS REVEALED AN EXCELLENT RANGE OF MOTION; STABILITY; AND RESTORATION OF ALIGNMENT. THE REVISION SURGICAL NOTES INDICATE A DEFINITE PALPABLE GAP BETWEEN THE QUADRICEPS TENDON AND THE MEDICAL MUSCULATURE. THE PATELLA WAS FOUND TO BE SUBLUXATED LATERALLY. SCARRING WAS IDENTIFIED IN THE LATERAL GUTTER. THIS WAS RESTORED AND THE PATELLA WAS THEN FOUND TO TRACK RELATIVELY WELL. IT IS NOTED THAT THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE WELL POSITIONED AND ALIGNED. THE ARTICULAR SURFACE WAS REVISED FROM A 14MM TO A 16MM. IT IS LIKELY THAT THE DEFECT BETWEEN MEDICAL MUSCULATURE AND THE QUADRICEPS TENDON ALONG WITH THE SCAR TISSUE WAS A CONTRIBUTING FACTOR IN THE REPORTED SUBLUXATION. EVALUATION CODES: THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION; THE NEED 3007963827-2013- 00028 PERSONA POSTERIOR STABILIZED FEMUR 8/14/13 4/10/13 Injury FOR CORRECTIVE ACTION IS NOT INDICATED. 3007963827-2013- 00029 PERSONA POSTERIOR STABILIZED FEMUR 8/14/13 4/10/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE DUE TO PAIN AND SUBLUXATION. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: THE IMPLANTED COMPONENTS WERE FOUND TO BE COMPATIBLE. THE IMPLANT SURGICAL NOTES INDICATE THAT THE PATIENT HAD A VARUS DEFORMITY WHICH REQUIRED DEEP RELEASE OF THE MCL. IT IS NOTED THAT THE TRIALS AND FINAL REDUCTIONS REVEALED AN EXCELLENT RANGE OF MOTION; STABILITY; AND RESTORATION OF ALIGNMENT. THE REVISION SURGICAL NOTES INDICATE A PALPABLE DEFECT BETWEEN THE VASTUS MEDIALIS AND THE QUADRICEPS TENDON. IT IS NOTED THAT THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE WELL POSITIONED. THE ARTICULAR SURFACE WAS REVISED FROM A 14MM TO A 16MM DUE TO MILD LAXITY. IT IS LIKELY THAT THE DEFECT BETWEEN THE VASTUS MEDIALIS AND THE QUADRICEPS TENDON WAS A CONTRIBUTING FACTOR IN THE REPORTED SUBLUXATION. EVALUATION: THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED; THE COMPLAINT WILL BE REOPENED. ZIMMER INC CONSIDERS THE INVESTIGATION CLOSED. Event Description: IT IS REPORTED THAT THE PT WAS REVISED DUE TO INSTABILITY. Manufacturer Narrative: INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE 1822565-2013- 01204 PERSONA VIVACIT- E ARTICULAR SURFACE 8/7/13 Injury AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 01164 PERSONA FEMORAL COMPONENT 7/26/13 6/26/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO A GLOBALLY TIGHT KNEE. Manufacturer Narrative: ALTHOUGH THE SURGEON WAS NOT ABLE TO TRIAL WITH THE 10MM CD ARTICULAR SURFACE; IT IS NOTED THAT THE PATIENT WAS DEEMED TO HAVE GOOD MOTION AND FULL EXTENSION WITH THE FINAL IMPLANTS DURING THE PROCEDURE. IS IT POSSIBLE THAT THE PATIENT'S ANATOMY CONTRIBUTED TO THE TIGHT KNEE JOINT. SCAR TISSUE OR OTHER CONDITIONS WITH SOFT TISSUES AND MUSCLES LIKELY PLAYED A ROLE IN THE ISSUE. THE INSTRUMENT CASES ARE MODULAR AND ARE SET- UP BY THE DISTRIBUTORSHIP OR SURGICAL FACILITY; WHICH IS OUTSIDE OF ZIMMER'S CONTROL. NO PRODUCT FAILURE HAS BEEN IDENTIFIED. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED; THE COMPLAINT WILL BE REOPENED. ZIMMER; INC. CONSIDERS THE INVESTIGATION CLOSED. REPORTED THAT THE SURGEON HAD DIFFICULTY INSERTING THE ARTICULAR SURFACE. A NEW ARTICULAR WAS OPENED AND 1822565-2013- 01130 PERSONA ARTICULAR SURFACE 7/19/13 6/21/13 Malfunction INSERTED WITHOUT A PROBLEM. 1822565-2013- 01131 PERSONA VE ARTICULAR SURFACE 7/19/13 Event Description: IT IS REPORTED THAT THE SURGEON HAD DIFFICULTY INSERTING THE ARTICULAR SURFACE. A NEW ARTICULAR WAS OPENED AND INSERTED WITHOUT A PROBLEM. Manufacturer Narrative: THIS REPORT WILL BE AMENDED 6/12/13 Malfunction WHEN OUR INVESTIGATION IS
Event Description: IT IS REPORTED THAT THE SURGEON WAS UNABLE TO PROPERLY INSERT THE ARTICULAR SURFACE. AFTER TRYING MULTIPLE TIMES; THE IMPLANT WAS DETERMINED TO BE NO GOOD AND ANOTHER ARTICULAR SURFACE WAS USED TO COMPLETE THE CASE. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THE SURGICAL TECHNIQUE STATES "INSERT AN ARTICULAR SURFACE ONLY ONCE. NEVER REINSERT THE SAME ARTICULAR SURFACE ONTO A TIBIAL BASE PLATE." MULTIPLE ATTEMPTS WERE MADE TO INSERT THE SAME ARTICULAR SURFACE WHICH MAY HAVE CONTRIBUTED TO THE ISSUE. THERE DOES NOT APPEAR TO BE AN ISSUE WITH THE RETURNED DEVICE. IT IS LIKELY THAT THE ARTICULAR SURFACE WAS NOT PROPERLY ORIENTED PRIOR TO INSERTION; HOWEVER; THIS CANNOT BE DETERMINED CONCLUSIVELY. THE ARTICULAR SURFACE WAS RETURNED WITH THE COMPLAINT FOR REVIEW. DIMENSIONAL ANALYSIS FOUND THE PART TO BE CONFORMING TO PRINT SPECIFICATIONS. VISUAL EXAMINATION SHOWS SOME DAMAGE TO THE DOVETAIL LOCKING FEATURE OF THE DEVICE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED; THE COMPLAINT WILL 1822565-2013- 01098 PERSONA POSTERIOR STABILIZED ART SURFACE 7/11/13 1/10/13 Malfunction BE REOPENED. ZIMMER; INC. CONSIDERS THE INVESTIGATION CLOSED. 2648920-2013- 00146 PERSONA STEMMED TIBIAL COMPONENT 7/10/13 Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE TIBIAL COMPONENT WAS MISSING THE SET SCREW TO HOLD THE PLUG INTO THE TIBIAL COMPONENT. THE SURGERY WAS 6/11/13 Malfunction COMPLETED WITH ANOTHER TIBIAL COMPONENT. Event Description: IT WAS REPORTED THAT A LEFT TIBIAL COMPONENT AND ARTICULAR SURFACE WERE IMPLANTED INTO A RIGHT KNEE WITH A RIGHT FEMORAL COMPONENT. Manufacturer Narrative: INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION 1822565-2013- 01081 PERSONA CEMENTED TIBIA 7/10/13 4/23/13 Injury IS 1822565-2013- 00965 PERSONA VIVACIT- E ARTICULAR SURFACE 6/12/13 5/13/13 Malfunction REPORTED THAT UPON OPENING THE IMPLANT; IT WAS OBSERVED THAT THERE WAS A HAIR ON IT. 1822565-2013- 00869 PERSONA TRABECULAR METAL TIBIAL COMPONENT 5/24/13 Event Description: IT IS REPORTED THAT AFTER THE TIBIAL IMPLANT WAS IMPACTED THE TRAY DID NOT APPEAR TO BE SECURE. BONE CEMENT WAS USED ON THE UNDERSIDE OF THE TRAY. Manufacturer Narrative: EVAL SUMMARY: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE; THE CONDITION OF THE COMPONENTS IS UNK. THE PERSONA TRABECULAR METAL SURGICAL TECHNIQUE STATES; "SLOWLY IMPACT THE TIBIAL PLATE UNTIL THE PEGS ARE APPROX HALF- WAY SEATED. PERFORM A VISUAL CHECK TO ENSURE THAT PEGS ARE STILL WELL ALIGNED TO THE HOLES PRIOR TO FULLY SEATING THE IMPLANT. ASSESS THE INITIAL STABILITY OF THE TIBIAL COMPONENT BY APPLYING MODERATE THUMB PRESSURE ON THE TIBIAL PLATE EITHER ANTERIORLY OR POSTERIORLY. IF MOVEMENT IS DETECTED; THE PERSONA TRABECULAR METAL TIBIAL TRAY SHOULD BE CEMENTED TO THE PROXIMAL TIBIA." THUS; THE EVENT DESCRIBED ABOVE IS PER THE SURGICAL TECHNIQUE AND IS INTENDED USE; IF THE PT'S BONE STOCK WAS POOR. IT IS UNK AT THIS TIME IF THE PT'S BONE STOCK WAS POOR. WITHOUT SUFFICIENT EVIDENCE; ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. EVAL - REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE RECEIVED; THE 4/26/13 Malfunction COMPLAINT WILL BE REOPENED. ZIMMER; INC. CONSIDERS THE INVESTIGATION CLOSED. Event Description: IT IS REPORTED THAT THE PATIENT'S 4 WEEK POST- OPERATIVE X- RAY SHOWED RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF TIBIA IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 00746 PERSONA STEMMED NATURAL TIBIA 5/2/13 Injury COMPLETED. 1822565-2013- 00736 PERSONA STEMMED NATURAL TIBIA COMPONENT 5/1/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT'S 4 WEEK POST OPERATIVE X- RAYS SHOWED RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF TIBIAL IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 00737 PERSONA STEMMED NATURAL TIBIA COMPONENT 5/1/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT'S 4 WEEK POST OPERATIVE X- RAYS SHOWED RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF TIBIAL IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 00730 PERSONA NATURAL TIBIA 5/1/13 Injury Event Description: IT WAS REPORTED THAT 4- WEEK POST- OPERATIVE XRAYS SHOW RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF THE TIBIAL IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 00738 PERSONA NATURAL TIBIA 5/1/13 Injury REPORTED THAT TIBIAL ANTERIOR RADIOLUCENCY HAS BEEN OBSERVED ON X- RAYS. 1822565-2013- 00732 PERSONA NATURAL TIBIA 5/1/13 Injury Event Description: IT WAS REPORTED THAT 4- WEEK POST- OPERATIVE XRAYS SHOW RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF THE TIBIAL IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 2648920-2013- 00106 PERSONA STEMMED NATURAL TIBIA 5/1/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT'S 4 WEEK POST OPERATIVE X- RAYS SHOWED RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF TIBIAL IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 00720 PERSONA STEMMED NATURAL TIBIA 5/1/13 Injury Event Description: IT IS REPORTED THAT THE PATIENT'S 4 WEEK POST OPERATIVE X- RAYS SHOWED RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF TIBIAL IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 00691 PERSONA NATURAL TIBIA 4/24/13 Injury Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT WAS REPORTED THAT 4- WEEK POST- OPERATIVE X- RAYS SHOW RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF THE TIBIAL IMPLANT. 1822565-2013- 00692 PERSONA NATURAL TIBIA 4/24/13 Injury Event Description: IT WAS REPORTED THAT 4- WEEK POST- OPERATIVE X- RAYS SHOW RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF THE TIBIAL IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 00690 PERSONA NATURAL TIBIA 4/24/13 Injury Event Description: IT WAS REPORTED THAT 4- WEEK POST- OPERATIVE X- RAYS SHOW RADIOLUCENCY ABOUT THE POSTERIOR ASPECT OF THE TIBIAL IMPLANT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2013- 00655 PERSONA ARTICULAR SURFACE PROVISIONAL 4/17/13 3/18/13 Malfunction REPORTED THAT THE ITEM HAS THE INCORRECT ITEM NUMBER ATTACHED ON IT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT WAS 1822565-2013- 00644 PERSONA CEMENTED CRUCIATE RETAINING FEMUR 4/17/13 Injury REPORTED THAT THE PATIENT DEVELOPED A RASH ONE WEEK AFTER SURGERY. 1822565-2013- 00660 PERSONA CEMENTED CRUCIATE RETAINING FEMUR 4/17/13 Injury Event Description: IT WAS REPORTED THAT THE PATIENT DEVELOPED A RASH FOUR WEEKS AFTER KNEE SURGERY. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT A BALL BEARING IS MISSING FROM THE TASP SHIM. Manufacturer Narrative: THIS 1822565-2013- 00502 PERSONA TIBIA ART SURFACE PROVISIONAL SHIM 3/21/13 Malfunction REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS Event Description: IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN; EFFUSION; AND LOOSENING. Manufacturer Narrative: UPON REVISION; IT WAS NOTED THAT THE BONE WAS VERY "GELATINOUS" UNDER THE FEMORAL; TIBIA; AND PATELLA COMPONENTS. X- RAYS WERE RETURNED AND IT WAS CONFIRMED THAT RADIOLUCENT LINES WERE PRESENT. IMPLANTS WERE NOT RETURNED HOWEVER; IT WAS REPORTED BY THE SURGEON THAT THE FEMORAL; TIBIAL; AND PATELLAR COMPONENT ALL HAD CEMENT IN THE CEMENT POCKETS/GROOVES OF THE IMPLANTS; AND LOOSENING OCCURRED AT THE CEMENT/BONE INTERFACE. WITH THE INFORMATION AVAILABLE; IT IS LIKELY THAT THE PATIENT'S BONE QUALITY AND/OR A PATIENT CONDITION CAUSED OR CONTRIBUTED TO THE LOOSENING THAT LED TO REVISION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE 3007963827-2013- 00002 PERSONA PS FEMUR COMPONENT 1/25/13 12/28/12 Injury REPORTED PROBLEM. BASED ON THE INVESTIGATION; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. Event Description: IT WAS REPORTED THAT THREE DIFFERENT SIZE 13 ARTICULAR SURFACES WERE ATTEMPTED FOR INSERTION BUT WOULD NOT SNAP INTO PLACE. A SIZE 14 SURFACE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. 2648920-2013- 00007 PERSONA FIXED BEARING ARTICULAR SURFACE 1/9/13 11/30/12 Malfunction Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2012- 02310 PERSONA CEMENTED TIBIAL DRILL 11/9/12 Event Description: IT WAS REPORTED THAT THE TIBIAL DRILL PERFORATED THE ANTEROMEDIAL CORTEX OF THE TIBIA. Manufacturer Narrative: INFO WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 10/9/12 Malfunction 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2012- 01814 PERSONA TIBIAL DRILL 8/23/12 Event Description: IT IS REPORTED THAT THE SURGEON DRILLED TOO FAR DOWN THE CANAL WHEN PREPARING FOR THE TIBIA. THE SPACE WAS FILLED WITH BONE CEMENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS EVAL SUMMARY: THE DRILL LINE THAT WAS USED WAS INDICATED FOR USE WHEN A STEM EXTENSION WAS BEING USED; WHICH WAS NOT BEING USED IN THIS CASE. THIS RESULTED IN THE CANAL BEING OVER DRILLED AND WAS FILLED WITH BONE CEMENT PRIOR TO IMPLANTING THE FINAL COMPONENT. EVAL: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION; THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD L 7/24/12 Malfunction SUBSTANTIVE INFO BE REC D; THE COMPLAINT WILL BE REOPENED. ZIMMER; INC. CONSIDERS THE INVESTIGATION CLOSED. 1822565-2012- 01679 PERSONA TIBIAL DRILL 8/7/12 Event Description: IT IS REPORTED THAT THE SURGEON TRIALED THE TIBIA. UPON PREPARING FOR THE IMPLANT HE NOTED THAT THE ANTERIOR CORTEX WAS VERY THIN AND TRANSLUCENT. Manufacturer Narrative: THIS REPORT WILL BE AMENDED 7/6/12 Malfunction WHEN OUR INVESTIGATION IS
Event Description: IT IS REPORTED THAT THE DRILL PERFORATED THE ANTERIOR CORTEX OF THE TIBIA. Manufacturer 1822565-2012- 01611 PERSONA TIBIAL DRILL 7/26/12 6/27/12 Malfunction Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2012- 01610 PERSONA TIBIAL DRILL 7/26/12 Event Description: IT IS REPORTED THAT THE PROXIMAL MEDIAL TIBIA WAS PERFORATED DURING SURGERY. Manufacturer 6/19/12 Malfunction Narrative: THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS 1822565-2012- 01232 PERSONA TGIBIAL DRILL 6/8/12 Event Description: IT IS REPORTED THAT THE TIBIAL DRILL PERFORATED THE TIBIAL CORTEX. THERE WAS THE PRESENCE OF CEMENT OUTSIDE THE MEDIAL ASPECT OF THE PROXIMAL TIBIA ON POST OPERATIVE X- RAYS. Manufacturer Narrative: THIS 5/11/12 Malfunction REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS