BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2254076 · Received September 19, 2011

    Report

    Report Number
    1818910-2011-18308
    Event Type
    Injury
    Date Received
    September 19, 2011
    Report Date
    August 22, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    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

    (B)(4) - PLAINTIFFS PRELIMINARY DISCLOSURE FORM WAS RECEIVED, WHICH IDENTIFIED (PART/LOT) INFORMATION. THE COMPLAINT AND ASSOCIATED MDRS WERE UPDATED. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    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). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT AFTER THE SURGICAL IMPLANTATION OF THE ASR HIP IMPLANT DEVICE, PLAINTIFF SUFFERED SYMPTOMS AND DAMAGE TO HER BODY INCLUDING, BUT NOT LIMITED TO CONSTANT AND SEVERE PAIN AND DISCOMFORT IN HER THIGH, HIP-JOINT, AND GROIN; THE FORMATION OF METALLOSIS AND PSEUDOTUMORS WHICH HAVE DAMAGED BONE AND TISSUE SURROUNDING THE IMPLANT; STIFFNESS; INFLAMMATION; CLICKING AND POPPING SENSATION IN HER HIP WHEN MOVING TO AND FROM A SITTING POSITION; INFECTION; CHROMIUM AND COBALT METAL TOXICITY; LACK OF MOBILITY; AND OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2006185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention