BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 3120471 · Received May 20, 2013

    Report

    Report Number
    1818910-2013-06802
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 30, 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

    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 THAT IN THE YEARS FOLLOWING HIS SURGERY, THE PATIENT SUFFERED FROM DISCOMFORT AND PAIN IN HIS HIP, GROIN, AND LEG. IT IS FURTHER ALLEGED THAT IT BECAME INCREASINGLY PAINFUL FOR HIM TO WALK, TO MOVE HIS LEG, AND TO RISE FROM A SEATED POSITION. DOI: 2007 - NO REVISION AT THIS TIME (LEFT SIDE) **UPDATE** (B)(6) 2013 - SALES REP REPORTED REVISION SURGERY ON LEFT HIP DUE TO ELEVATED ION LEVELS. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222536 ASR UNI FEMORAL IMPL SIZE 51 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2173117

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention