BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 49

    MDR report key: 3102971 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-05751
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    December 2, 2012
    Report Date
    April 29, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    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

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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

    ASR REVISION; LEFT; ASR XL; REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION, INCREASED METAL ION LEVELS, NOISE AND PERI PROSTHETIC FLUID NOTED IN MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203047 DEPUY ASR XL FEM IMP SIZE 49 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2446658

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention