BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 47

    MDR report key: 2972187 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-02596
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    October 5, 2012
    Report Date
    August 15, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    UPDATED DATA: (DATE OF REPORT); (EVENT DESCRIPTION); (DATE RECEIVED BY MANUFACTURER); (EVALUATION CODES). 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

    ASR REVISION;ASR XL - LEFT HIP;REASON FOR REVISION: COMPONENT LOOSENING.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - LEFT HIP; REASON(S) FOR REVISION: COMPONENT LOOSENING - STEM; LYSIS IN ACETABULUM; PAIN; ALVAL/SOFT TISSUE REACTION; METALLOSIS AROUND TAPER; PROXIMA FEMUR AND TAPER WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76100 DEPUY ASR XL FEM IMP SIZE 47 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2029308

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention