BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD

    MDR report key: 2151159 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-12154
    Event Type
    Injury
    Date Received
    June 30, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    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

    FAILURE DUE TO NECROSIS OF PERI-IMPLANT BONE AND SOFT TISSUE FROM MASSIVE METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL HEAD TOTAL HIP PROSTHESIS KWY DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention