BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APR HOODED ACETABULAR INSERT 32MM/57MM

    MDR report key: 51514 · Received November 26, 1996

    Report

    Report Number
    2935620-1996-00013
    Event Type
    Injury
    Date Received
    November 26, 1996
    Date of Event
    May 5, 1996
    Report Date
    November 21, 1996
    Manufacturer
    INTERMEDIA ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    H6. METHOD - 86 OTHER. REVIEWED INSPECTION/MFG RECORDS WITH NO DISCREPANICES FOUND. ALSO, REVIEWED PT RECORDS FOR FIRST TWO YEARS OF POST-OP EVAL NOTING NO PAIN, NORMAL ACTIVITY, AND NO OSTEOLYSIS. H6. RESULTS - 100, 200, 300, 400 OTHER: SUFFICIENT DATA WAS NOT MADE AVAILABLE TO DETERMINE ACTUAL CAUSE(S) FOR FAILURE.

    Description of Event or Problem · 1

    NOTICE OF IDE REVISION SURGERY TO THE MFR. REVISION OF THE RIGHT HIP OF A BILATERAL PT. (STUDY #G850061).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APR HOODED ACETABULAR INSERT 32MM/57MM Implant HIP IMPLANT PROTHESIS KWB INTERMEDIA ORTHOPEDICS, INC. NA 7530

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention