BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR UNI FEMORAL IMPL SIZE 43

    MDR report key: 2771612 · Received October 4, 2012

    Report

    Report Number
    1818910-2012-23185
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    July 26, 2012
    Report Date
    September 27, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT SUFFERS DEBILITATING PAIN AND DISCOMFORT THAT INTERFERES WITH HER ABILITY TO PERFORM ACTIVITIES OF DAILY LIVING AS SHE OTHERWISE NORMALLY WOULD. (B)(4) 2012 - PATIENTS OPERATIVE NOTES RECEIVED. IT WAS NOTED THE PATIENT HAD MIGRATION OF HER LEFT ACETABULAR COMPONENT AND AN AREA OF INDURATION AND INFLAMMATION SECONDARY TO THIRD BODY WEAR FROM METAL-ON-METAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 43 TOTAL HIP REPLACEMENT KWA DEPUY INTERNATIONAL 2362258

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention