BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYCAD UNICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 11664928 · Received April 14, 2021

    Report

    Report Number
    3012086398-2021-00001
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 18, 2021
    Report Date
    June 17, 2021
    Manufacturer
    BODYCAD
    Product Code
    HSX
    PMA / PMN Number
    K163700
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED TIBIAL BASE PLATE WAS EXAMINED VISUALLY. THE PURPOSE OF THIS INVESTIGATION WAS TO DETERMINE THE CAUSE FOR THE FRACTURE OF THE TIBIAL BASE PLATE. THE BASE PLATE WAS FRACTURED INTO TWO PIECES. EXAMINATION OF THE FRACTURE SURFACE REVEALED THAT FATIGUE WAS THE FRACTURE MECHANISM DUE TO THE PRESENCE OF FATIGUE STRIATIONS. EXAMINATION ALSO REVEALED LACK OF CEMENT ADHESION TO THE POSTERIOR ASPECT OF THE PLATEAU WHICH COULD POTENTIALLY LEAD TO LOOSENING. THE CAUSE OF THE TIBIAL BASE PLATE FRACTURE WAS LIKELY DUE TO FATIGUE LOADING IN EXCESS OF THE STRENGTH OF THE TRAY NOT PROPERLY SUPPORTED BY THE BONE / CEMENT INTERFACE.

    Description of Event or Problem · 0

    FOLLOWING A PAIN COMPLAINT BY PATIENT AN X-RAY SHOWS THE DAMAGE TO THE TIBIAL BASE PLATE. SURGICAL INTERVENTION, REVISION KNEE SURGERY, FOR BREACKING OF TIBIAL BASEPLATE WAS PERFORMED..

    Additional Manufacturer Narrative · 1

    BECAUSE OF ELECTRONIC REPORTING ISSUES IN ESG TEST, THIS REPORT IS SENT LATE. ALL TECHNICAL SUPPORT IS NOW IN PLACE TO AVOID THIS KIND OF DELAY LATER.

    Description of Event or Problem · 1

    PATIENT HAD NO ASSOCIATED TRAUMA OR FALL. PATIENT PRESENTED TO DR WITH PAIN . X-RAY SHOWS A BROKEN TIBIAL TRAY. RETRIEVAL PICTURE SHOW A BROKEN TIBIAL BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565759 BODYCAD UNICOMPARTMENTAL KNEE SYSTEM UNICOMPARTMENTAL KNEE, HSX BODYCAD 010003

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention