BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMP HIP

    MDR report key: 6143801 · Received December 3, 2016

    Report

    Report Number
    1644408-2016-00939
    Event Type
    Injury
    Date Received
    December 3, 2016
    Date of Event
    November 6, 2016
    Report Date
    January 13, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LPH
    UDI-DI
    00888912084031
    PMA / PMN Number
    K974093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS AN INFECTION. THE PREVIOUS SURGERY AND THE REVISION DETAILED IN THIS INVESTIGATION OCCURRED 26 DAYS APART. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE POSSIBLE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE IMPLANT DEVICE HISTORY RECORDS (DHRS) SHOW THAT THE REPORTED COMPONENT USED IN THE PREVIOUS SURGERY MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS (NCMRS) ASSOCIATED WITH THE PRODUCT THAT MAY HAVE CONTRIBUTED TO AN INFECTION. THE DEVICE WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN IT'S EXPIRATION DATE AT THE TIME OF USE DURING THE PREVIOUS SURGERY. THERE WERE NO FINDINGS DURING THIS INVESTIGATION THAT INDICATE THAT THE REPORTED DEVICE WAS THE ROOT CAUSE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION. DUE TO THE SHORT TIME BETWEEN THE ORIGINAL SURGERY AND THE REVISION, IT IS POSSIBLE THAT THE INFECTION WAS ACQUIRED IN THE HOSPITAL (NOSOCOMIAL). IT IS ALSO POSSIBLE THAT THE PATIENT WAS NOT COMPLIANT WITH POST SURGICAL INSTRUCTIONS. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT'S HIP BEING INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794201 FMP HIP FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 54MM, W/P2 COATING LPH ENCORE MEDICAL, L.P. 590G1143 00888912084031

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 400-03-362,LOT 866B1184| 425-97-009,LOT 174R1049| 932-36-754,LOT 814N1936