BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD INSERT

    MDR report key: 2150995 · Received June 29, 2011

    Report

    Report Number
    1818910-2011-11662
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    September 9, 2005
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K001523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY HAS RECEIVED (B)(4) ULTIMA TPS FEMORAL STEM EXPLANTS FROM THE (B)(6). THESE CONSIST LARGELY OF COMPONENTS FROM A CLINICAL STUDY. THE EXPLANTED STEMS HAVE DISPLAYED SOME EVIDENCE OF CORROSION ON THE SURFACE OF THE IMPLANT. THIS HAS BEEN REPORTED BY THE KEY SURGEONS FROM THE (B)(6) IN A CLINICAL PAPER ((B)(4)). FOLLOWING PREVIOUS CLINICAL REVIEW IN (B)(4) 2007, DEPUY HAD PROVIDED INFORMATION TO USERS REGARDING OUR FINDINGS AND OFFERED GUIDANCE ON THE FUTURE CLINICAL MANAGEMENT OF PATIENTS. ON (B)(4) 2007 THE (B)(4) ISSUED A MEDICAL DEVICE ALERT TO USERS ((B)(4)). THE ULTIMA TPS HIPS SYSTEM IS NO LONGER AVAILABLE ON THE MARKET FOR CLINICAL USE. MOST OF THE EXPLANTS RECENTLY RECEIVED ARE FAILURES REPORTED IN CLINICAL PAPER AND WHICH LEAD TO THE 2007 MDA [1] (19 OF WHICH HAD PREVIOUSLY BEEN INVESTIGATED THOUGH THE COMPLAINTS SYSTEM). THEY WERE COLLECTED IN THE (B)(6) AND PASSED TO US FOR ANALYSIS IN 2011. A FEW ARE FROM FURTHER REVISIONS CARRIED OUT AFTER THE MDA FROM THE ORIGINAL COHORT OF PATIENTS. PREVIOUS INVESTIGATION CONDUCTED ON ULTIMA TPS FEMORAL STEM EXPLANTS HAS BEEN PERFORMED IN CONJUNCTION WITH (B)(4) AND IS DOCUMENTED ON (B)(4). ADDITIONAL INVESTIGATION WILL BE DOCUMENTED (B)(4). THIS ANALYSIS INCLUDES INVESTIGATION INTO THE REASON FOR THE CORROSION OF THE TPS STEM (B)(4). THE EXPLANTS WILL BE HELD WITH RD AS PART OF THE (B)(4) INVESTIGATION AND UPON COMPLETION WILL BE HANDED TO QUALITY FOR ARCHIVE. A HEALTH HAZARD EVALUATION ((B)(4)) IS ONGOING AT THIS TIME. ACTION NONE AT THIS TIME SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    NECROSIS OF PERI-IMPLANT BONE AND SOFT TISSUE FROM MASSIVE METALLOSIS AND LATE DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD INSERT 87KWA KWA DEPUY INTERNATIONAL, LTD NA XVN-88

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention