BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYCAD UNICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 9136660 · Received September 30, 2019

    Report

    Report Number
    3012086398-2019-00002
    Event Type
    Injury
    Date Received
    September 30, 2019
    Date of Event
    September 6, 2019
    Report Date
    September 30, 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 4 WEEKS, THE PATIENT REPORTED PAIN. X-RAYS DEMONSTRATED TIBIAL FRACTURE AND ANTERIOR SUBSIDENCE OF THE TIBIAL COMPONENT. THE IMPLANT WAS REVISED TO A PRIMARY CR KNEE. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. NO ROOT CAUSE COULD BE IDENTIFIED FOR THIS ADVERSE EVENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND EVALUATION IS ONGOING. SHOULD ANY ADDITIONAL INFORMATION CHANGE THE CONCLUSION ON THE ROOT CAUSE, 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 REPORTED PAIN AFTER 4 WEEKS. AT DIAGNOSIS, TIBIAL FRACTURE AND ANTERIOR SUBSIDENCE OF THE TIBIAL COMPONENT WERE OBSERVED. THE PROSTHESIS WAS REVISED TO A TOTAL KNEE (CR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930819 BODYCAD UNICOMPARTMENTAL KNEE SYSTEM UNICOMPARTMENTAL KNEE HSX BODYCAD LABORATORIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R