BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 1911688 · Received November 29, 2010

    Report

    Report Number
    1818910-2010-08986
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 16, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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

    PT WAS REVISED TO ADDRESS ACETABULAR LOOSENING. PAPERWORK FROM A WORKERS COMPENSATION CLAIM WERE FORWARDED TO THE DEPUY LEGAL DEPARTMENT. INCLUDED WAS THE REVISION OPERATIVE REPORT WHICH INDICATED THAT THE PT HAD ELEVATED CHROMIUM AND COBALT LEVELS. BECAUSE OF THIS ADDITIONAL INFO, THE COMPLAINT HAS BEEN REOPENED TO INCLUDE THE FEMORAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2401073

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention