BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2012708 · Received February 24, 2011

    Report

    Report Number
    1818910-2011-03122
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    DEPUY INTL LTD
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 SLIGHT LOOSENING OF THE CUP, WHICH WAS NOT GROSSLY LOOSE, BUT HAD NO BONY INGROWTH. SIGNS OF ALVAL WERE ALSO PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 87KWA KWA DEPUY INTL LTD NA 2378531

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention