BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2862936 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-25466
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    August 1, 2012
    Report Date
    November 16, 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
    CA, 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. NOT RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS ACETABULAR CUP LOOSENING. LITIGATION PAPERS ALLEGE THE PATIENT CONTINUES TO EXPERIENCE PAIN IN HER LEFT HIP AND SUFFERS FROM INJURIES OF A PERMANENT, LASTING, AND PAINFUL NATURE AS A DIRECT AND PROXIMATE RESULT OF THE ASR SYSTEMS FAILURE. PAPERS FURTHER ALLEGE THE PATIENTS ABILITY TO PERFORM AND ENJOY REGULAR ACTIVITIES HAS BEEN IMPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 TOTAL HIP REPLACEME KWA DEPUY INTERNATIONAL 2465420

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention