BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 54

    MDR report key: 2933868 · Received January 29, 2013

    Report

    Report Number
    1818910-2013-01820
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 20, 2013
    Report Date
    October 24, 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

    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

    DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL - RIGHT HIP; REASON(S) FOR REVISION: COXARTHROSIS AND PERIPROSTHETIC OSTEOLYSIS (PERIACETABULAR).

    Description of Event or Problem · 1

    ADDITIONAL REASON FOR REVISION: COMPONENT LOOSENING - ACETABULAR CUP, NOISE, ELEVATED METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39752 ASR ACETABULAR IMPLANT 54 ASR TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 1997421

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention