BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUGMENTED INSERT

    MDR report key: 2150848 · Received June 29, 2011

    Report

    Report Number
    1818910-2011-11614
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    August 28, 2007
    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 108 ULTIMA TPS FEMORAL STEM EXPLANTS FROM THE (B)(6) ORTHOPAEDIC HOSPITAL. 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) NOVEMBER 2010). FOLLOWING PREVIOUS CLINICAL REVIEW IN MARCH 2007, DEPUY HAD PROVIDED INFORMATION TO USERS REGARDING OUR FINDINGS AND OFFERED GUIDANCE ON THE FUTURE CLINICAL MANAGEMENT OF PATIENTS. ON THE (B)(4) 2007 THE MHRA 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 THROUGH 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 REVIEW OF THE DEVISE HISTORY RECORD FOR LOT NUMBER 1141704, 1125760 AND 1040588 FOUND NO ANOMALIES. THIS INVESTIGATION WILL BE CLOSED WITH AN UNDETERMINABLE CONCLUSION. CORRECTIVE ACTION NONE AT THIS TIME. A HEALTH HAZARD EVALUATION ((B)(4)) IS ONGOING AT THIS TIME. CORRECTIVE ACTION NONE 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

    NECROSIS OF PERI-IMPLANT BONE AND SOFT TISSUE FROM MASSIVE METALLOSIS CAUSED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUGMENTED INSERT 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 1125760

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention