BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR XL TAP SLV ADAP 12/14+2

    MDR report key: 2002423 · Received February 18, 2011

    Report

    Report Number
    1818910-2011-02164
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    March 12, 2010
    Report Date
    January 19, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    CORRECTED: EVENT/PROBLEM DESCRIPTION, BRAND NAME, CATALOG #/LOT #, EXPLANT DATE. 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).

    Description of Event or Problem · 1

    THE PT HAS HAD AN ASR REVISION. SPECIFIC DETAILS REGARDING THE REVISION ARE UNK.

    Description of Event or Problem · 1

    ASR REVISION RIGHT HIP - EVIDENCE OF METALLOSIS. THICKENED CAPSULE AND SOME WERE SENT OFF FOR PATHOLOGY TESTING. WAITING ON PATHOLOGY. X-RAY PHOTOS AVAILABLE. EXPLANTS BEING STERILIZED FOR RETURN TO DEPUY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR XL TAP SLV ADAP 12/14+2 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2177800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention