BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 58

    MDR report key: 3122324 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-05867
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 10, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KXA
    Removal / Correction Number
    Z- 1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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. REF. (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. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS A DUPLICATE OF REPORT 1818910-2013-05866. DEPUY CONSIDERS THIS MEDWATCH VOID AND CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    ASR REVISION, ASR XL - LEFT, REASON(S) FOR REVISION: ALVAL / SOFT TISSUE REACTION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223951 ASR ACETABULAR IMPLANT 58 ASR TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL 2050143

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention