BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 2175524 · Received July 21, 2011

    Report

    Report Number
    1818910-2011-13611
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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 INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE PT HAS SUFFERED, AND CONTINUES TO SUFFER, INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO, EMOTIONAL DISTRESS, PAST, PRESENT AND FUTURE PHYSICAL AND MENTAL PAIN AND SUFFERING; PAST, PRESENT AND FUTURE MEDICAL, HOSPITAL, MONITORING, REHABILITATIVE AND PHARMACEUTICAL EXPENSES, AND LOST WAGES, EXCESSIVE EXPOSURE TO METAL CONTAMINATION OF HIS BLOOD AND BODY BY COBALT AND CHROMIUM AND OTHER SUBSTANCES TOXIC TO THE PT, LOSS OF EXPECTANCY OF LIFE, EXPOSURE TO HIGHER THAN NORMAL RATES OF CANCER, ORGAN FAILURE, AND OTHER POTENTIAL FUTURE HEALTH COMPLICATIONS. UPDATE: THE SALES REP REPORTED THE REVISION SURGERY. THE PT WAS REVISED TO ADDRESS PAIN AND A SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 47 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2937743

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention