BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM

    MDR report key: 14485682 · Received May 24, 2022

    Report

    Report Number
    3005180920-2022-00395
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 27, 2022
    Report Date
    May 24, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896774
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28 APRIL 2022. LOT 2103557: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2021. EXPIRATION DATE: 2026-05-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR. FEW WEEKS AFTER PRIMARY UNICOMPARTMENTAL ARTHROPLASTY A FRACTURE OCCURS AND THE SURGEON DECIDES TO CONVERT TO A TOTAL KNEE. THE RADIOGRAPHS ATTACHED ARE OF VERY LOW QUALITY AND NO EVALUATION IS POSSIBLE. THERE IS NO MENTION OF A TRAUMATIC EVENT. THE BONE FRACTURE MUST HAVE BEEN CAUSED EITHER BY A TRAUMA OR BY THE INEVITABLE WEAKENING OF THE BONE CONSEQUENT TO THE SURGICAL PROCEDURE. IN EITHER CASE, WE SEE NO REASON TO SUSPECT THAT A DEFECTIVE DEVICE IS AT THE ROOT OF THIS ADVERSE EVENT.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AND HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM A MOTO TO SPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517640 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S5 LM CEMENTED PARTIAL TIBIAL TRAY HSX MEDACTA INTERNATIONAL SA 02.18.TF5.LM 2103557 07630030896774

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention