BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESERVATION UNI FEM CEM SZ2

    MDR report key: 1053436 · Received May 27, 2008

    Report

    Report Number
    1818910-2008-01741
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    DEPUY - CORK, A DIV OF DEPUY ORTHOPAEDICS
    Product Code
    HRY
    PMA / PMN Number
    K010810
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICES FOUND EVIDENCE SUGGESTING POOR FIXATION OF THE FEMORAL COMPONENT. NO EVIDENCE WAS FOUND OF ACCELERATED/UNEXPECTED POLYETHYLENE WEAR. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE POOR DEVICE FIXATION. NO EVIDENCE WAS FOUND SUGGESTING PROD ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADD'L INFO BE REC'D, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS LOOSENING OF FEMORAL COMPONENT/CEMENT INTERFACE, CEMENT MANUFACTURED BY OTHERS. POLYETHYLENE WEAR AND SYNOVITIS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESERVATION UNI FEM CEM SZ2 87HRY HRY DEPUY - CORK, A DIV OF DEPUY ORTHOPAEDICS NA 2024198

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention