BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMK FEMORAL SIZE 2+ LT

    MDR report key: 1233634 · Received November 14, 2008

    Report

    Report Number
    1818910-2008-05411
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    July 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K864671
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PRODUCTS WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MFG LOTS. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED DISLOCATIONS; HOWEVER, PROVIDED INFO INDICATED POOR DEVICE ALIGNMENT WAS A POSSIBLE CONTRIBUTING FACTOR. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMK FEMORAL SIZE 2+ LT 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA TX1A71005

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention