BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION HIP

    MDR report key: 7419298 · Received April 10, 2018

    Report

    Report Number
    1644408-2018-00332
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Date of Event
    March 28, 2018
    Report Date
    May 4, 2018
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LPH
    UDI-DI
    00888912084048
    PMA / PMN Number
    K974093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: THIS MDR WILL BE VOIDED. THE SCREW REMAINED IN THE PATIENT WITH THE ORIGINAL IMPLANT. NOTHING WAS REMOVED AND SURGERY WAS COMPLETED AS INTENDED.

    Description of Event or Problem · 1

    REPORTED INCIDENT - ACETABULAR BONE SCREW APPEARED TO ADVANCE BEYOND THE CLUSTER HOLE OF THE FMP SHELL. THE SCREW WAS DRILLED USING THE FMP DRILL GUIDE, SHORT 3.3 MILLIMETER DRILL BIT, AND FMP DRILL BIT SHAFT. AN FMP DEPARTMENT GAUGE WAS USED TO MEASURE THE SCREW LENGTH AND THE 40 MILLIMETER SCREW WAS INSERTED BY HAND BY THE SURGEON. THE REAL LINER WAS THEN IMPACTED IN PLACE IN USUAL FASHION. UPON REVIEW OF THE INTRA OPERATIVE X-RAY FOR THE FEMORAL BROACH, IT WAS NOTICED THAT THE ACETABULAR BONE SCREW APPEARED TO HAVE ADVANCED FARTHER THAN THE BOTTOM OF THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254539 FOUNDATION HIP FMP HEMISPHERICAL SHELLS W/SCREW HOLES, 56MM, W/P2 COATING LPH ENCORE MEDICAL L.P. 430-98-056 591G1228 00888912084048

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 010-55-040, LOT 010A1138