BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMP HIP

    MDR report key: 3843804 · Received June 2, 2014

    Report

    Report Number
    1644408-2014-00333
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    OQG
    PMA / PMN Number
    K130365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KEPT BY HOSPITAL.

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS DUE TO A DISLOCATION AFTER 21 DAYS OF PATIENT USE. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE HOSPITAL KEPT THE DEVICE; IT WAS NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS PRODUCT. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT FOR A PART FROM THIS LOT. THE ROOT CAUSE OF THE DISLOCATION WAS REPORTEDLY DUE TO THE PATIENTS ANATOMY. THERE IS NO INFORMATION REPORTED THAT SHOWED A MATERIAL, DESIGN, OR MANUFACTURING PROBLEM WITH THE PRODUCT.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT'S ANATOMY, THE PATIENT DISLOCATED. THE SURGEON REMOVED THE HEAD AND REPLACED IT WITH LONG HEAD AND SLEEVE OPTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321648 FMP HIP LINER/10 DEGREE HOODED - NEUTRAL, HXE-PLUS, MP 8 36MM OQG ENCORE MEDICAL, L.P. 814N1003

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention