BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULR CUP 50

    MDR report key: 2800261 · Received October 22, 2012

    Report

    Report Number
    1818910-2012-76895
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    March 6, 2012
    Report Date
    August 16, 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
    PA, UK
    Reporter Occupation
    ATTORNEY

    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). 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

    DEPUY CONSIDERS THIS COMPLAINT CLOSED AT THIS TIME.

    Description of Event or Problem · 1

    LITIGATION PAPERS RECEIVED THAT ALLEGE THE PATIENT SUFFERED FROM DAMAGE TO THE TISSUES AND STRUCTURE OF THE HIP; INFLAMMATORY AND LYMPHOCYTIC RESPONSE; HEADACHES; FATIGUE AND EXHAUSTION; SYNOVITIS; HYPERACTIVE SYNOVIUM; BURSAL AND JOINT SCARRING; CHROMIUM AND COBALT TOXICITY AND COMPLICATIONS THEREFROM; AVASCULAR NECROSIS; PHYSICAL PAIN; DISFIGUREMENT, MENTAL ANGUISH AND ANXIETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULR CUP 50 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2872798

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention