BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2963692 · Received February 15, 2013

    Report

    Report Number
    1818910-2013-03875
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 30, 2013
    Report Date
    May 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    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. (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

    PATIENT WAS REVISED DUE TO MILD DISCOMFORT AND ELEVATED ION LEVELS.

    Description of Event or Problem · 1

    UPDATE: DATE (B)(6) 2013, LITIGATION PAPERS RECEIVED. LITIGATION PAPERS ALLEGE PAIN, IMPLANT FAILURE AND BONE AND TISSUE DAMAGE. SIDE PROVIDED. (RIGHT HIP) THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69329 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD KWA DEPUY INTERNATIONAL 2719088

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR