BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 54

    MDR report key: 2426218 · Received January 24, 2012

    Report

    Report Number
    1818910-2012-02114
    Event Type
    Injury
    Date Received
    January 24, 2012
    Report Date
    January 3, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    ADDED: BRAND NAME, COMMON DEVICE NAME, CATALOG #/LOT #, EXPLANT DATE, PMA/510(K) #, MANUFACTURE DATE. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: THE PATIENT COULD NOT HAVE KNOW THAT HE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE HE HAD HIS BLOOD DRAWN AND HE WS ADVISED OF THE RESULTS OF SAID BLOOD WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 54 TOTAL HIP KWA DEPUY INTERNATIONAL 2568304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other