BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3023221 · Received March 27, 2013

    Report

    Report Number
    1818910-2013-02821
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    November 17, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP IMPLANT ON HIS LEFT HIP ON OR ABOUT (B)(6) 2007. PATIENT HAS EXPERIENCED PERSISTENT SEVERE PAIN AND DISCOMFORT IN HIS LEFT HIP, BUTTOCKS, GROIN, AND THIGH, WHICH HAS INCREASED OVER TIME; WEAKNESS, AND DECREASED RANGE OF MOTION. PATIENT SUFFERS FROM SUBSTANTIALLY ELEVATED LEVELS OF COBALT AND CHROMIUM METAL IONS IN HIS BLOODSTREAM. UPON INFORMATION AND BELIEF, PATIENT IS SUFFERING LOSS OF MUSCLE MASS AND DETERIORATION OF THE SOFT TISSUE IN HIS HIP. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT. UPDATE PLAINTIFFS FACT SHEET FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125076 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2439556

    Patients

    Seq Age Sex Outcome Treatment
    1 Other