BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 45

    MDR report key: 2071456 · Received April 13, 2011

    Report

    Report Number
    1818910-2011-06487
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS LOOSENING OF THE STEM AND CUP, WHICH HAD NO BONY INGROWTH. THE REVISION OPERATIVE REPORT WAS NOT INCLUDED; HOWEVER, A PATHOLOGY REPORT POST REVISION SURGERY INDICATES PERISYNOVIAL AND FIBROLIGAMENTOUS TISSUE WITH LYMPHOHISTIOCYTIC INFLAMMATION AND FOCAL GIANT CELL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 45 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2711363

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention