BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR XL HEAD

    MDR report key: 5821986 · Received July 26, 2016

    Report

    Report Number
    1818910-2016-23924
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    August 10, 2015
    Report Date
    July 5, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KXA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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. WWCAPA (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

    THIS IS A DUPLICATE REPORT OF 181910-2015-29168. THIS REPORT, 1818910-2016-23924, WILL BE REJECTED. REPORT # 181910-2015-29168 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Description of Event or Problem · 1

    LITIGATION DOCUMENTS RECEIVED. LITIGATION ALLEGES THAT THE PATIENT UNDERWENT A REVISION TO ADDRESS METALLOSIS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475762 UNKNOWN DEPUY ASR XL HEAD HIP FEMORAL HEAD KXA DEPUY INTERNATIONAL LTD. 8010379 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention