BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2990757 · Received March 5, 2013

    Report

    Report Number
    1818910-2013-04248
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    June 20, 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
    IL, 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.

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    PATIENT IS SEEKING LEGAL ACTION. NO ADDITIONAL INFORMATION IS AVAILABLE. UPDATE: (B)(4) 2013 SALES REP REPORTS THAT THE PATIENT WAS REVISED BECAUSE OF PAIN, CUP HAD LITTLE TO NO INGROWTH.

    Description of Event or Problem · 1

    UPDATE: (B)(6) 2013-LITIGATION PAPERS RECEIVED ALLEGING THAT THE PATIENT SUFFERS FROM VARIOUS METALLIC ELEMENTS IN BLOOD. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE INVESTIGATIONAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94216 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2153949

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention