BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2912338 · Received January 11, 2013

    Report

    Report Number
    1818910-2013-00292
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    August 23, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    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

    UPDATE 10/2/15 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE ASR SLEEVE AND STEM ARE BEING ADDED FOR THE ALLEGED HIGH METAL IONS (NO LABS PROVIDED). THE COMPLAINT WAS UPDATED ON:10/26/2015.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERED ACHES AND PAIN IN THE THIGH AND HIP AND BUTTOCK AREA, STIFFNESS AND DIFFICULTY, BODILY INJURIES, PHYSICAL PAIN, DISFIGUREMENT AND/OR DEFORMITY AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16271 ASR UNI FEMORAL IMPL SIZE 45 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2212977

    Patients

    Seq Age Sex Outcome Treatment
    1 Other