BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL ACETABULAR SYSTEM

    MDR report key: 2093707 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08329
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT
    Health Professional
    N

    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 CONTACTED BROADSPIRE TO INITIATE CLAIM. PT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNK. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XL ACETABULAR SYSTEM TOTAL HIP REPLACEMENT KWA DEPUY INTL., LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention