BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 47

    MDR report key: 3033862 · Received April 3, 2013

    Report

    Report Number
    1818910-2013-01674
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    December 2, 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
    NY, 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. H3 OTHER TEXT : NOT RECEIVED

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT PATIENT EXPERIENCED PAIN AND SUFFERING; DISABILITY; IMPAIRMENT; LOSS OF FUNCTION, USE AND RANGE OF MOTION; DECREASED AND POOR HIP PERFORMANCE; GAIT DISTURBANCE; METALLIC AND OTHER PARTICULATE CONTAMINATION OF THE BLOOD AND BODY; EXACERBATION OF UNDERLYING HIP JOINT DISORDERS; INTERNAL SCARRING; AND IRRITATION AND INJURY TO THE TENDONS, LIGAMENTS, MUSCLES, BLOOD VESSELS, CARTILAGES, NERVES, BONES AND SOFT TISSUES OF THE HIP JOINT AND SURROUNDING AREAS. PATIENT HAS NOT YET SCHEDULED AN EXPLANTATION OF THE ASR HIP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137324 ASR UNI FEMORAL IMPL SIZE 47 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2239215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other