BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPLANT SIZE 47

    MDR report key: 2211805 · Received August 10, 2011

    Report

    Report Number
    1818910-2011-14773
    Event Type
    Injury
    Date Received
    August 10, 2011
    Report Date
    July 11, 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
    NC, US
    Reporter Occupation
    ATTORNEY

    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

    PATIENT FACT SHEET (PFS) FORMS AND IMPLANT STICKERS RECEIVED WHICH IDENTIFIED PART/LOT INFORMATION. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. DEPUY STILL 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

    PATIENT IS A RESIDENT OF TX.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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER LEFT SIDE ON OR ABOUT (B)(6), 2007. IN (B)(6) 2008, PT BEGAN EXPERIENCING SEVERE HIP, THIGH, AND GROIN PAIN; PAIN WHILE SITTING FOR PROLONGED PERIODS OF TIME; PAIN WHILE LYING ON HER SIDE; AND PAIN WHILE WALKING. SHE WAS ALSO INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT. IT IS NOT CLEAR WHETHER PT HAS BEEN REVISED ON HER LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPLANT SIZE 47 FEMORAL HEAD HIP IMPLANT KWA DEPUY INTERNATIONAL, LTD. NA 2471315

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention