BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S1 RM

    MDR report key: 12058170 · Received June 24, 2021

    Report

    Report Number
    3005180920-2021-00507
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 24, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896705
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31 MAY 2021: LOT 170788: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2017. EXPIRATION DATE: 2022-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION: 1.5 YEARS AFTER PRIMARY UKA THE TIBIAL COMPONENT LOOSENED AND REQUIRED REVISION. FROM THE RADIOGRAPHS SUPPLIED, IT SEEMS THAT THE MEDIAL PROXIMAL TIBIAL BONE LOST DENSITY AND BECAME UNABLE TO SUSTAIN THE BASEPLATE, FOR UNKNOWN REASONS. ACCORDING TO THE SURGEON'S ANALYSIS, THE BASEPLATE COULD NOT BE SEATED FULLY ON CORTICAL BONE, PARTICULARLY IT DID NOT REACH THE ANTERIOR TIBIAL CORTEX. THIS IS OF COURSE A GOOD EXPLANATION, BUT THE IMAGES WE HAVE AVAILABLE ARE NOT SUFFICIENT FOR US TO CONFIRM THIS HYPOTHESIS. WE DON'T SEE ANY REASON TO SUSPECT A FAULTY IMPLANT.

    Description of Event or Problem · 1

    REVISION DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT 1 YEAR AND 4 MONTHS AFTER PRIMARY. ALL DEVICES WERE EXPLANTED AND GMK SPHERE SYSTEM WAS IMPLANTED. IT MAY BE THAT THE ANTERIOR PART OF THE TIBIAL IMPLANT WAS NOT PERFECTLY SEATED ON THE CORTICAL BONE. THE PATIENT HAS A RATHER HIGH BMI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960560 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S1 RM FIXED CEMENTED TIBIAL TRAY HSX MEDACTA INTERNATIONAL SA 02.18.TF1.RM 170788 07630030896705

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention