BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2093844 · Received May 12, 2011

    Report

    Report Number
    1818910-2011-08181
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 12, 2011
    Report Date
    March 20, 2026
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    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
    UNKNOWN

    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

    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 PATIENT SUFFERED SYMPTOMS AND DAMAGE TO HER BODY INCLUDING BUT NOT LIMITED TO CONSTANT AND SEVERE PAIN AND DISCOMFORT IN HER THIGH, GROIN, HIP-JOINT, AND BACK, SENSATION THAT HIP WILL GIVE OUT ON HER WHEN SHE STANDS, PAIN AND DISCOMFORT WHENEVER MOVING TO AND FROM A SITTING POSITION, METALLOSIS DAMAGING THE BONE AND TISSUE SURROUNDING THE IMPLANT,SWELLING, INFECTION AND INFLAMMATION OF SURROUNDING BONE AND TISSUE, A LACK OF MOBILITY, AND CHROMIUM AND COBALT METAL TOXICITY. IT IS FURTHER ALLEGED THAT THE PAIN AND DISCOMFORT AND FEAR THAT HER HIP IS GOING TO GIVE OUT ON HER HAS AFFECTED HER ABILITY TO LIVE A NORMAL LIFE, TO WORK, OR RESUME NORMAL LEISURE ACTIVITIES SHE HAD PERFORMED IN THE PAST. THE SALES REP REPORTED THE REVISION SURGERY. THE PATIENT WAS REVISED TO ADDRESS HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2171745

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention