BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 2822843 · Received October 26, 2012

    Report

    Report Number
    MW5027481
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    August 20, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SYNTHES, INC
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BB EXPERIENCED A FEMORAL FRACTURE RELATED TO BISPHOSOPHONATES ON (B)(6) 2012. A LCP PROXIMAL FEMORAL HOOK PLATE BY SYNTHES WAS USED TO REPAIR THE FRACTURE. AFTER A VERY COMPLICATED POST OP BB WAS DISCHARGED TO A NURSING HOME THEN TO AN ASSISTED LIVING FACILITY AND RETURNED HOME IN (B)(6). DURING THAT TIME SHE HAD MINIMAL AMBULATION AND WEIGHT BEARING. ON (B)(6) 2012, SHE SAID IT FELT LIKE HER LEG CAVED IN. SHE WAS TAKEN TO THE EMERGENCY AND FOUND THAT THE SYNTHES FEMUR HOOK HAD TOTAL BROKEN IN HALF. THE FRACTURE SITE HAD NOT CHANGE SINCE THE LAST FOLLOW - UP FILMS. THE PT WAS TRANSPORTED TO A LARGER FACILITY WHERE THE BROKEN HARDWARE WAS REMOVED AND A ROD INSERTED TO STABILIZE THE HEALING FRACTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES LCP PROXIMAL FEMORAL HOOK PLATE HRS SYNTHES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R