BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN ALL POLY PATELLA

    MDR report key: 5637591 · Received May 6, 2016

    Report

    Report Number
    0002648920-2016-00830
    Event Type
    Injury
    Date Received
    May 6, 2016
    Date of Event
    May 4, 2015
    Report Date
    May 17, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRIMARY OPERATIVE NOTES CONFIRM THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2008 FOR OSTEOARTHRITIS. REVIEW OF THE PRIMARY OPERATIVE NOTES DOES NOT INDICATE ROOT CAUSE. A MEDIAL COLLATERAL LIGAMENT RELEASE WAS PERFORMED TO BALANCE THE KNEE TO VARUS AND VALGUS STRESSES. FULL FLEXION AND EXTENSION WERE REPORTED WITH EXCELLENT STABILITY. PER THE REVISION SURGERY NOTES, DURING THE PROCEDURE, COPIOUS AMOUNT OF CLEAR STRAW-COLORED FLUID WAS OBTAINED. EXAMINATION OF THE KNEE JOINT REVEALED A WELL-AFFIXED FEMORAL COMPONENT. THERE WAS COLD-FLOW POLYETHYLENE WEAR OF THE PATELLA AND LOOSENING OF THE TIBIAL TRAY. IT WAS INDICATED THAT THE TIBIAL TRAY WAS PISTONING AND THERE WAS OBVIOUS LOOSENING. THERE WAS EXCELLENT STABILITY BOTH WITH FLEXION AND EXTENSION AND PATELLAR TRACKING WAS QUITE WELL WITH FINAL COMPONENTS. THERE WERE NO APPARENT COMPLICATIONS AND PATIENT WAS STABLE POST-OP. THIS DEVICE IS USED FOR TREATMENT. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT INCLUDING COLD FLOW OF THE PATELLA POLYETHYLENE AND LOOSENING OF THE MIS TIBIAL COMPONENT REMAINS UNKNOWN WITH THE INFORMATION PROVIDED. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE TIBIAL LOOSENING MAY BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION IN APRIL 2010. A FIELD ACTION (ZFA 2010-013) WAS CONDUCTED ON APRIL 19, 2010, IN WHICH ZIMMER STRONGLY RECOMMENDS THE USE OF A DROP DOWN STEM EXTENSION IN CONJUNCTION WITH THE BASEPLATE AND CONFIRMING THE CORRECT TECHNIQUE FOR CEMENTING THE NEXGEN MIS TIBIAL COMPONENT WAS FOLLOWED. THIS ISSUE HAS BEEN INVESTIGATED AND ADDRESSED BY CAPA (B)(4). A DROP-DOWN STEM EXTENSION WAS USED HOWEVER, IT CANNOT BE SAID IF COMPONENTS WERE ADEQUATELY CEMENTED. THE IMPLANTS RELATED TO THIS EVENT WERE IMPLANTED PRIOR TO THE FIELD ACTION. FDA RECALL Z-2412-2010 CONTAINS THE RELATED PART NUMBER. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED FOR LOOSENING OF THE TIBIAL TRAY AND COLD FLOW WEAR OF PATELLA WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED THROUGH REVIEW OF MEDICAL RECORDS. THE RETURNED DEVICES EACH EXHIBIT NICKS, GOUGES AND SCRATCHES THROUGHOUT THE SURFACES. THE ROOT CAUSE PREVIOUSLY REPORTED REMAINS UNCHANGED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 1822565-2013-01505, 0002648920-2016-00830.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN AND FEMORAL AND TIBIAL LOOSENING. DURING THE REVISION, COLD-FLOW POLYETHYLENE WEAR OF THE PATELLA WAS NOTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS COMPONENT LOOSENING APPROXIMATELY SIX (6) YEARS AND FIVE (5) MONTHS POST-OPERATIVELY. REVISION OPERATIVE NOTES NOTED COPIOUS AMOUNT OF CLEAR, STRAW-COLORED FLUID. THE FEMORAL COMPONENT WAS WELL-AFFIXED, HOWEVER, THERE WAS COLD-FLOW POLYETHYLENE WEAR OF THE PATELLA AND OBVIOUS LOOSENING OF THE TIBIAL TRAY. EXCELLENT STABILITY WITH FLEXION, EXTENSION AND PATELLAR TRACKING WAS OBTAINED WITH NEW COMPONENTS AND THE PATIENT WAS IN STABLE CONDITION POST-OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293277 NEXGEN ALL POLY PATELLA JWH JWH ZIMMER MANUFACTURING B.V. N/A 61113010

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R