BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 62

    MDR report key: 2192469 · Received July 15, 2011

    Report

    Report Number
    1818910-2011-12982
    Event Type
    Injury
    Date Received
    July 15, 2011
    Report Date
    June 17, 2011
    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
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE 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 SINCE PATIENT'S SURGICAL IMPLANT OF THE ASR HIP, PATIENT HAS RECENTLY BEGAN TO SUFFER AND CONTINUES TO SUFFER SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, WEAKNESS, AND DIFFICULTY WITH EVEN SIMPLE DAILY ACTIVITIES. IT IS FURTHER ALLEGED IN (B)(6), 2011, PATIENT'S PHYSICIANS DISCOVERED HIGH LEVELS OF CHROMIUM AND COBALT METAL IONS AND HAVE PLANNED A REVISION IN THE VERY NEAR FUTURE DUE TO CONSTANT PAIN AND POTENTIAL ELEVATED METAL IONS. IT IS ALSO ALLEGED PATIENT HAS SUFFERED SIGNIFICANT HARM, INCLUDING BUT NOT LIMITED TO PHYSICAL INJURY AND BODILY IMPAIRMENT, DEBILITATING LACK OF MOBILITY AND CONSISTENT AND CONTINUAL PAIN AND SUFFERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 62 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2141312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention