BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 5651336 · Received May 12, 2016

    Report

    Report Number
    1818910-2016-19229
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    December 3, 2015
    Report Date
    April 29, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.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

    (B)(4). DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS IS A DUPLICATE REPORT OF 181910-2011-16837. THIS REPORT, 1818910-2016-19229, WILL BE REJECTED. MFR #181910-2011-16837 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT UNDERWENT A REVISION TO ADDRESS SERIOUS BODILYINJURY AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305280 ASR UNI FEMORAL IMPL SIZE 51 HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 2946157

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention