BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTAL ASR ACET IMP SIZE 54

    MDR report key: 1942495 · Received November 29, 2010

    Report

    Report Number
    1818910-2010-08803
    Event Type
    Other
    Date Received
    November 29, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 30, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510K# SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS PAIN CAUSED BY A LOOSE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL ASR ACET IMP SIZE 54 87KWA KWA DEPUY INTERNATIONAL, LTD NA 2316506

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention