BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2213425 · Received August 12, 2011

    Report

    Report Number
    1818910-2011-15195
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 14, 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
    WI, 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. REF (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

    PATIENT FACT SHEET (PFS) FORM RECEIVED WHICH IDENTIFIED THE LOT INFORMATION AND PATIENT'S DATE OF BIRTH. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME.

    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 PT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES: PAST MEDICAL EXPENSES, FUTURE MEDICAL EXPENSES, PAST LOST WAGES, FUTURE LOST WAGES, PAST AND FUTURE CONSCIOUS PAIN AND SUFFERING, PHYSICAL INJURY, BODILY IMPAIRMENT, MENTAL ANGUISH, EMOTIONAL DISTRESS AND LOSS OF ENJOYMENT OF LIFE. IT IS ALSO ALLEGED THE PT COULD NOT HAVE KNOWN THAT SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE SHE HAD HER BLOOD DRAWN AND SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK. PT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERED THE FOLLOWING PERSONAL AND ECONOMIC INJURIES: PAST MEDICAL EXPENSES, FUTURE MEDICAL EXPENSES, PAST LOST WAGES, FUTURE LOST WAGES, PAST AND FUTURE CONSCIOUS PAIN AND SUFFERING, PHYSICAL INJURY, BODILY IMPAIRMENT, MENTAL ANGUISH, EMOTIONAL DISTRESS AND LOSS OF ENJOYMENT OF LIFE. IT IS ALSO ALLEGED THE PATIENT COULD NOT HAVE KNOWN THAT SHE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT UNTIL AFTER THE DATE SHE HAD HER BLOOD DRAWN AND SHE WAS ADVISED OF THE RESULTS OF SAID BLOOD-WORK. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT. UPDATE: 1/16/12 - 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 UNI FEMORAL IMPL SIZE 46 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL, LTD. NA 2583880

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention