BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMP HIP

    MDR report key: 3863840 · Received June 10, 2014

    Report

    Report Number
    1644408-2014-00353
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    JDI
    PMA / PMN Number
    K935263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS REPORTED AS DISLOCATION AFTER 30 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. HOSPITALIZATION - INITIAL OR PROLONGED WAS REQUIRED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED 1 NON-CONFORMING MATERIAL REPORT (NCMR) ASSOCIATED WITH THIS PRODUCT. NCMR 21033 SHOWED 20 PARTS (PART NUMBER: 4001221) RETURNED TO THE VENDOR FOR MISSING MARKINGS. A REVIEW OF THE PRODUCT COMPLAINT REPORT HISTORY SHOWED THIS IS THE FIRST COMPLAINT FOR THIS PART NUMBER FROM THIS LOT. THE ROOT CAUSE FOR THE DISLOCATION WAS REPORTED AS A FALL. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT STATED SHE HAD FALLEN AND DISLOCATED HER HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341299 FMP HIP COCR HEAD NEUTRAL 22MM JDI ENCORE MEDICAL, L.P. 777B1105

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R