BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 51

    MDR report key: 2902037 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-00137
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    January 31, 2010
    Report Date
    March 27, 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 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.

    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). DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    THE REVISION WAS DUE TO THE ACETABULAR COMPONENT LOOSENING AND WAS NOT RELATED TO THE FEMORAL HEAD.

    Description of Event or Problem · 1

    ADDITIONAL REASONS FOR REVISION: PAIN; COMPONENT MALALIGNMENT; ALVAL/SOFT TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8812 DEPUY ASR XL FEM IMP SIZE 51 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2401071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention