BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYCAD UNICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 8682811 · Received June 10, 2019

    Report

    Report Number
    3012086398-2019-00001
    Event Type
    Injury
    Date Received
    June 10, 2019
    Date of Event
    May 23, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BODYCAD LABORATORIES INC.
    Product Code
    HSX
    PMA / PMN Number
    K181302
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A RIGHT KNEE PARTIAL ARTHROPLASTY. AFTER 6 WEEKS, THE PATIENT REPORTED PAIN AND THE JOINT WAS UNSTABLE DUE TO SUBSIDENCE OF THE TIBIAL COMPONENT. IT WAS NOTED THAT THE DEVICE HAD NO DEFECT AND THAT THE CEMENT INTERFACE WAS INTACT. THE IMPLANT WAS REVISED TO A PRIMARY CR KNEE. EXPLANTS WERE NOT MADE AVAILABLE TO THE MANUFACTURER. 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. THE REASON FOR IMPLANT SUBSIDENCE IS UNKNOWN. 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.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A RIGHT KNEE PARTIAL ARTHROPLASTY. THE PATIENT REPORTED PAIN AFTER 6 WEEKS. AT DIAGNOSIS, SUBSIDENCE OF THE TIBIAL PLATEAU WAS OBSERVED. THE PROSTHESIS WAS REVISED TO A TOTAL KNEE (CR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475799 BODYCAD UNICOMPARTMENTAL KNEE SYSTEM UNICOMPARTMENTAL KNEE HSX BODYCAD LABORATORIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R