BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY ASR IMPLANTS

    MDR report key: 2823693 · Received December 10, 2010

    Report

    Report Number
    1818910-2010-10852
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    DEPUY INTL LTD
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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

    ASR REVISION RECOMMENDED - LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR IMPLANTS 87KWA KWA DEPUY INTL LTD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention