BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3183123 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-04474
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 15, 2011
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 ALLEGES AFTER THE IMPLANT OF THE DEVICE, PATIENT EXPERIENCED SEVERE PAIN AND DISCOMFORT, EXHIBITED THE SYMPTOMS OF A LOOSE IMPLANT AND, BASED ON INFORMATION AND BELIEF, HAS SUFFERED A LOSS OF MUSCLE MASS. IT IS FURTHER ALLEGED PATIENT CANNOT AMBULATE WITHOUT ASSISTANCE AND HAS SUFFERED AND WILL CONTINUE TO SUFFER DAMAGES, INCLUDING, BUT NOT LIMITED TO PAST, PRESENT, AND FUTURE PAIN AND SUFFERING, DISABILITY, DISFIGUREMENT, EXPENSES FOR MEDICAL, HOSPITAL, MONITORING, REHABILITATIVE AND PHARMACEUTICAL COSTS. PATIENT IS BILATERAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282737 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2727787

    Patients

    Seq Age Sex Outcome Treatment
    1 Other