BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 49

    MDR report key: 2232854 · Received August 18, 2011

    Report

    Report Number
    1818910-2011-14209
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 21, 2011
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS IMPLANT IS NOT SOLD IN THE US TO BE IMPLANTED FOR THIS INDICATION; IT WOULD BE SOLD UNDER A DIFFERENT PART NUMBER SINCE IT IS ONLY INDICATED TO BE USED AS A HEMI IN THE U.S. AT THIS TIME. THE CORRECTIVE/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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

    CLINICAL STUDY - ASR REVISION DUE TO CYSTS AND MUSCLE WEAKNESS (RIGHT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 49 87KWA KWA DEPUY INTL., LTD. NA 2469294

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention