BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 16146455 · Received January 12, 2023

    Report

    Report Number
    3005180920-2022-00973
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    December 13, 2022
    Report Date
    January 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 DECEMBER 2022: LOT 2002929: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2020. EXPIRATION DATE: 2025-06-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANTS: BATCH REVIEW PERFORMED ON 15 DECEMBER 2022 ON GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3+ L (K140826) LOT. 1908855. LOT 1908855: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2019. EXPIRATION DATE: 2024-12-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 15 DECEMBER 2022 ON GMK-SPHERE 02.12.0310FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L (K121416) LOT. 2001699. LOT 2001699: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2020. EXPIRATION DATE: 2025-03-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE OF PAIN IS UNKNOWN. AT ABOUT 2 YEARS AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE TIBIAL TRAY, FEMORAL COMPONENT AND TIBIAL INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238279 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1203L 2002929 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention