BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 51

    MDR report key: 2113159 · Received May 20, 2011

    Report

    Report Number
    1818910-2011-08788
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 22, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(6) 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

    PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE CUP, WHICH HAD MINIMUM TO NO INGROWTH. PRELIMINARY REVISION OPERATIVE REPORT RECEIVED. ALTHOUGH THE OPERATIVE REPORT IDENTIFIES THE PRODUCTS AS PINNACLE, THE SALES REP REPORTED PART/LOT INFORMATION FOR ASR DEVICES. ADDITIONALLY, THE REVISION REPORT STATES THAT UPON ENTERING THE CAPSULE, THERE WAS AN OBVIOUS LARGE COLLECTION OF CLEAR YELLOW FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 51 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2163402

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention