BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEMORAL IMP SZ 46

    MDR report key: 1842572 · Received September 17, 2010

    Report

    Report Number
    1818910-2010-06884
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 20, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT WAS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT WAS SOLD IN THE UNITED STATES UNDER A DIFFERENT PART NUMBER. 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

    (B)(4) REPORTS: REVISION SURGERY. THE DEVISE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVISE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEMORAL IMP SZ 46 TOTAL HIP REPLACEMENT KWY DEPUY INTERNATIONAL, LTD. NA 201404

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention