BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2071702 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06365
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 16, 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

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

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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.

    Description of Event or Problem · 1

    SEE ATTACHED MEDWATCH REPORT: THE PT HAD A HIP REPLACEMENT FOR A FRACTURE THAT FAILED SEVERAL YEARS AGO. AT SOME POINT SHE HAD THIS CONVERTED TO A TOTAL HIP REPLACEMENT, WHICH TOOK ABOUT 6 HOURS. SHE HAS HAD PAIN EVER SINCE AND THE CUP WAS A RECALLED DEPUY PROSTHESIS. THE PHYSICIAN THOUGHT SHE MAY HAVE METALLOSIS OR FAILURE AS THE CUP WAS PUT IN SOMEWHAT VERTICAL AND SHE WAS BROUGHT FOR SURGERY TO EXPLORE THE HIP. THE PT WAS ADMITTED AND HAD SURGERY FOR PLACEMENT OF THE HIP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention