BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUGMENTED INSERT

    MDR report key: 2150958 · Received June 29, 2011

    Report

    Report Number
    1818910-2011-11778
    Event Type
    Injury
    Date Received
    June 29, 2011
    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 Location
    UK
    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. A HEALTH HAZARD EVALUATION ((B)(4)) IS ONGOING AT THIS TIME.

    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

    FAILURES WERE DUE TO NECROSIS OF PERI-IMPLANT BONE AND SOFT TISSUE FROM MASSIVE METALLOSIS, PAIN AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUGMENTED INSERT 87KWA KWA DEPUY INTERNATIONAL, LTD. NA XVN-92

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention