BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 1942521 · Received December 1, 2010

    Report

    Report Number
    1818910-2010-09133
    Event Type
    Other
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    PT WAS REVISED TO ADDRESS ELEVATED BLOOD SERUM LEVELS FOR COBALT AND CHROME. THE SYNOVIAL FLUID HAD A WHITE, MILKY APPEARANCE, AND THE SURROUNDING TISSUES APPEARED REACTIVE. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 87KWA KWA DEPUY INTERNATIONAL, LTD NA 2303687

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention