BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 51

    MDR report key: 6196529 · Received December 21, 2016

    Report

    Report Number
    1818910-2016-33845
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 10, 2016
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWY
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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 UNDERWENT A REVISION TO ADDRESS ALVAL/SOFT TISSUE REACTION, METALLOSIS, OSTEOLYSIS, ELEVATED METAL IONS, PAIN AND STEM LOOSENING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845734 DEPUY ASR XL FEM IMP SIZE 51 HIP FEMORAL HEAD KWY DEPUY INTERNATIONAL LTD. 8010379 2173116

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention