BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 3183172 · Received June 21, 2013

    Report

    Report Number
    1818910-2013-06384
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    June 6, 2013
    Report Date
    September 9, 2013
    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
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    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.

    Description of Event or Problem · 1

    **UPDATE** - MEDICAL RECORDS RECEIVED (B)(4) 2013. REVISION OPERATIVE REPORT INDICATES THE FOLLOWING: CLOUDY, BROWN-STAINED FLUID; BROWN FIBRINOUS DEBRIS WITHIN THE SYNOVIUM AS WELL AS IN THE HOLLOWED OUT BACK SURFACE OF THE ASR FEMORAL HEAD. CORROSION IN THE MORSE TAPER WHICH WAS MILD AND DID NOT DEFORM OR STRUCTURALLY COMPROMISE THE TAPER; SMALL OSTEOLYTIC LESION. ADAPTER SLEEVE AND FEMORAL STEM ADDED TO COMPLAINT.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT HAS SUFFERED FROM EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284010 ASR UNI FEMORAL IMPL SIZE 49 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2325385

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention