BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 11900857 · Received May 28, 2021

    Report

    Report Number
    3005180920-2021-00449
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    May 3, 2021
    Report Date
    May 28, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 MAY 2021: LOT 1904222: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2019. EXPIRATION DATE: 2024-10-26. 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. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 14 MAY 2021: GMK-SPHERE 02.12.0411FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L (K140826) LOT 189007: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2019. EXPIRATION DATE: 2024-01-21. 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.

    Description of Event or Problem · 1

    11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A RUPTURED PATELLA TENDON AND THE CAUSE OF THE RUPTURED PATELLA TENDON IS UNKNOWN. THE SURGEON REPAIRED THE PATELLA TENDON AND REVISED TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801340 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1204L 1904222 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention