BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP HEAD, 10/12 TAPER, 28MM, +0MM

    MDR report key: 2151144 · Received June 30, 2011

    Report

    Report Number
    1818910-2011-12080
    Event Type
    Injury
    Date Received
    June 30, 2011
    Report Date
    May 31, 2011
    Manufacturer
    DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    K893872
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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. (PERIPROSTHETIC FRACTURE, PAIN AND LATE DISLOCATION ALSO REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP HEAD, 10/12 TAPER, 28MM, +0MM 87KWY KWY DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC. NA 653232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention