BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 16900770 · Received May 10, 2023

    Report

    Report Number
    3005180920-2023-00352
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 14, 2023
    Report Date
    May 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6)2023. LOT 2239788: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JAN-2023. EXPIRATION DATE: 2027-12-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0006L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L (K121416) LOT 2219805: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-NOV-2022. EXPIRATION DATE: 2027-11-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0512FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L (K121416) LOT 2101705: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APR-2021. EXPIRATION DATE: 2026-04-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 10 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO TEARING OF THE MCL DURING THE PRIMARY AND SUBSEQUENT INSTABILITY. THE SURGEON REVISED THE ALL COMPONENTS FROM GMK-SPHERE TO GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686803 GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1205L 2239788 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention