BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 52

    MDR report key: 2071486 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06662
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 16, 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

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    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 AFTER SURGERY, PATIENT SUFFERED SYMPTOMS AND DAMAGE TO HER BODY INCLUDING BUT NOT LIMITED TO SEVERE PAIN AND DISCOMFORT AND SORENESS IN HER THIGH, GROIN, AND HIP-JOINT; CLICKING AND GRINDING SENSATION IN THE HIP AREA WHEN MOVING; METALLOSIS DAMAGING THE BONE AND TISSUE SURROUNDING THE IMPLANT, A LACK OF MOBILITY, INABILITY TO SIT FOR LONG PERIODS, INABILITY TO RIDE IN A CAR, INABILITY TO WALK LONG DISTANCES, AND CHROMIUM AND COBALT METAL TOXICITY.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE AFTER SURGERY, PATIENT SUFFERED SYMPTOMS AND DAMAGE TO HER BODY INCLUDING BUT NOT LIMITED TO SEVERE PAIN AND DISCOMFORT AND SORENESS IN HER THIGH, GROIN, AND HIP-JOINT; CLICKING AND GRINDING SENSATION IN THE HIP AREA WHEN MOVING; METALLOSIS DAMAGING THE BONE AND TISSUE SURROUNDING THE IMPLANT, A LACK OF MOBILITY, INABILITY TO SIT FOR LONG PERIODS, INABILITY TO RIDE IN A CAR, INABILITY TO WALK LONG DISTANCES, AND CHROMIUM AND COBALT METAL TOXICITY. UPDATE: 4/18/2012 - PLAINTIFF'S 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. UPDATE: (B)(6) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 52 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL NA 2368952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention