BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 3150871 · Received June 6, 2013

    Report

    Report Number
    1818910-2013-05510
    Event Type
    Injury
    Date Received
    June 6, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANT DATES WERE PROVIDED AS (B)(6) 2008, (B)(6) 2009. IT WAS NOT IMMEDIATELY CLEAR WHICH PRODUCTS WERE EXPLANTED AT WHICH TIME. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED. 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 PAPERS ALLEGE THE PATIENT WAS REVISED BECAUSE THE HIP IMPLANT HAD FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251140 ASR UNI FEMORAL IMPL SIZE 45 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL 2205797

    Patients

    Seq Age Sex Outcome Treatment
    1 Other