BEUDAMED
    FDA Adverse Event Other Summary report: N

    MCS LINER

    MDR report key: 1629951 · Received March 10, 2010

    Report

    Report Number
    1038671-2010-00023
    Event Type
    Other
    Date Received
    March 10, 2010
    Date of Event
    February 3, 2010
    Report Date
    February 10, 2010
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED LINER INDICATES EVIDENCE OF DEFORMATION UNDER THE RIM OF THE LINER, CONSISTENT WITH DAMAGE CAUSED BY REMOVAL ATTEMPTS. THERE WAS ALSO DEFORMATION OF THE LINER AROUND THE RIM OF THE INNER DIAMETER CONSISTENT WITH FEMORAL NECK/LINER CONTACT. A VISUAL EXAMINATION DID NOT INDICATE A QUALITY, DESIGN OR MANUFACTURING ISSUE.

    Description of Event or Problem · 1

    HIP COMPONENTS WERE REVISED AND RETURNED TO MANUFACTURER WITH NO DETAILS OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCS LINER NONE LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention