BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BC REFLEX UNI

    MDR report key: 11805189 · Received May 11, 2021

    Report

    Report Number
    3012086398-2021-00002
    Event Type
    Injury
    Date Received
    May 11, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BODYCAD LABORATORIES, INC
    Product Code
    HSX
    UDI-DI
    00688346000061
    PMA / PMN Number
    196996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A RIGHT KNEE PARTIAL ARTHROPLASTY. AFTER 30 DAYS, THE PATIENT REPORTED PAIN A X-RAYS DEMONSTRATED TIBIAL FRACTURE . IT WAS NOTED THAT THE DEVICE HAD NO DEFECT AND REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE EVENT WAS NOT CAUSED BY WRONG LABELING OR WRONG INSTRUCTIONS FOR USE. BODYCAD CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED AND A FOLLOW-UP MEDICAL DEVICE REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A RIGHT KNEE PARTIAL ARTHROPLASTY. THE PATIENT PAIN AFTER 30 DAYS POST IMPLANTATION DUE TO FRACTURED TIBIA BONE. CLEAR FRACTURE IN THE ANTERIOR PART OF THE TIBIA. FRACTURE WAS NOT DISPLACED. THE DOCTOR TREATED THE PATIENT CONSERVATIVELY WITH SCREWS ACROSS THE FRACTURE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700934 BC REFLEX UNI UNICOMPARTMENTAL KNEE HSX BODYCAD LABORATORIES, INC 018001 00688346000061

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention