BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 3062516 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-03156
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    December 22, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    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: PERSISTENT SEVERE PAIN AND DISCOMFORT IN HIS RIGHT HIP, GROIN AND THIGH, WHICH HAS INCREASED OVER TIME; SENSATION OF MISALIGNMENT, WEAKNESS, DECREASED RANGE OF MOTION, AND DIFFICULTY WITH ACTIVITIES OF DAILY LIVING SUCH AS WALKING AND STANDING AFTER BEING SEATED. PHYSICIANS ADVISED PATIENT THAT HE SUFFERS FROM ELEVATED LEVELS OF COBALT METAL IONS IN HIS BLOOD STREAM DUE TO THE FAILED HIP. IN (B)(6) 2010, PATIENT'S COBALT LEVEL WAS 2.2. UPON INFORMATION AND BELIEF, PATIENT IS SUFFERING LOSS OF MUSCLE MASS AND DETERIORATION OF THE SOFT TISSUE IN HIS HIP. THIS CAN CAUSE SIGNIFICANT HEALTH PROBLEMS, THE EXACERBATION OF PRE-EXISTING CONDITIONS, WHILE SUBJECTING THE PATIENT TO INCREASE MEDICAL DIAGNOSIS AND TREATMENTS. **UPDATE** (B)(6) 2011 PLAINTIFF'S PRELIMINARY DISCLOSURE FORM WAS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166239 ASR UNI FEMORAL IMPL SIZE 46 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2202445

    Patients

    Seq Age Sex Outcome Treatment
    1 Other