BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1903164 · Received November 12, 2010

    Report

    Report Number
    1818910-2010-08569
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE NECESSARY PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. ALTHOUGH THE ROOT CAUSE CANNOT BE DETERMINED, IT IS KNOWN THAT THE ASR PLATFORM WAS VOLUNTARILY RECALLED IN AUGUST OF 2010 FOLLOWING AN HHE (HEALTH HAZARD EVALUATION). FURTHER ANALYSIS WILL BE DOCUMENTED ON WWCAPA (B)(4) . BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION IS NOT INDICATED AT THIS TIME. 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

    PATIENT CONTACTED (B)(6) TO INITIATE CLAIM. PATIENT REPORTED REVISION SURGERY. REASON FOR REVISION IS UNK. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP TOTAL HIP REPLACEMENT KWY DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention