BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2190831 · Received July 22, 2011

    Report

    Report Number
    1818910-2011-13762
    Event Type
    Injury
    Date Received
    July 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    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 SINCE SURGICAL IMPLANT, PATIENT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO PAIN AND LACK OF MOBILITY. IT IS FURTHER ALLEGED, PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING BUT NOT LIMITED TO PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY, CONSCIOUS PAIN AND SUFFERING, AND LOSS OF EARNINGS. IT IS ALSO ALLEGED, PATIENT TESTED POSITIVE FOR ELEVATED LEVELS OF CHROMIUM AND COBALT POISONING. IT IS ALSO ALLEGED PATIENT HAS HAD A REVISION SURGERY, PHYSICAL THERAPY AND OTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention