BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY DURALOC CUP

    MDR report key: 1895178 · Received November 8, 2010

    Report

    Report Number
    1818910-2010-08553
    Event Type
    Injury
    Date Received
    November 8, 2010
    Report Date
    October 14, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Description of Event or Problem · 1

    PATIENT REVISED FOR PAIN, RADIOGRAPH REVEALED LOCKING RING FAILURE, ECCENTRICITY OF HEAD AND PELVIC/FEMORAL OSTEOLYSIS. LINER SHOWED SUPERIOR WEAR, SCRATCHES FROM LOCKING RING FRAGMENTS AND SIGNS OF IMPINGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY DURALOC CUP TOTAL HIP REPLACEMENT KWA DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention