BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DEPUY ASR IMPLANTS

    MDR report key: 1943976 · Received December 3, 2010

    Report

    Report Number
    1818910-2010-08568
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Report Date
    November 3, 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

    ALTHOUGH THE SPECIFIC NATURE OF THE PT'S COMPLAINT IS UNK, BECAUSE REVISION HAS BEEN RECOMMENDED BY DEPUY'S THIRD PARTY CLAIMS ADMINISTRATOR, IT IS REASONABLE TO CONCLUDE THAT THE PT'S COMPLAINT HAS BEEN DETERMINED TO BE PRODUCT-RELATED. 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

    RECOMMENDED ASR REVISION.

    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