BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2111548 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08346
    Event Type
    Injury
    Date Received
    May 13, 2011
    Report Date
    April 14, 2011
    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
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). 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

    (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    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

    LITIGATION PAPERS ALLEGE AFTER SURGICAL IMPLANTATION, PT SUFFERED SYMPTOMS AND DAMAGE TO HER BODY INCLUDING BUT NOT LIMITED TO SEVERE PAIN AND DISCOMFORT IN HER GROIN, THIGH, KNEE, LOWER BACK, AND HIP; A RESTRICTED RANGE OF MOTION IN THE HIP-JOINT; INABILITY TO PERFORM NORMAL DAILY LIVING FUNCTIONS; CLICKING, GRINDING AND POPPING OF THE IMPLANT WHEN SHE WALKED AND WENT TO AND FROM A SITTING POSITION; INFECTION AND INFLAMMATION OF BONE AND TISSUE SURROUNDING THE IMPLANT; METALLOSIS; LACK OF MOBILITY; AND CHROMIUM AND COBALT METAL TOXICITY. PT WILL UNDERGO REVISION SURGERY IN THE SUMMER OR FALL OF 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL NA 2589631

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention