BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L

    MDR report key: 16458789 · Received March 1, 2023

    Report

    Report Number
    3005180920-2023-00103
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    January 30, 2023
    Report Date
    March 1, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 FEBRUARY 2023: LOT 2102494: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2021. EXPIRATION DATE: 2026-04-22. 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. VISUAL INSPECTION PERFORMED BY R&D KNEE MANAGER: FROM VISUAL INSPECTION NO ANOMALIES CAN BE NOTED ON THE EXPLANTED DEVICES THAT COULD HAVE PLAYED A ROLE IN THE EVENT. NO RESIDUAL CEMENT ON THE TIBIA BASEPLATE AND NO RESIDUAL BONE CAN BE NOTED ON THE INTERNAL SURFACE OF THE FEMUR INTENDED TO BE IN CONTACT WITH THE BONE. THIS IS NOT AN EVIDENCE OF LACK OF FIXATION; IN FACT, IN THE EVENT DESCRIPTION, LOOSENING HAS NOT BEEN REPORTED. YELLOW MARKINGS CAN BE SEEN ON THE EXPLANTED TIBIAL INSERT. THIS TURNING OF THE COLOR INTO YELLOW IN SOME PORTIONS OF THE UHMWPE COMPONENTS. THIS IS SOMETHING THAT AFFECTS ONLY THE EXTERNAL SURFACES OF THE INSERT AND NOT RELATED TO ABNORMAL OXIDATION OF THE LINER. FROM VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE. ADDITIONAL DEVICES INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 06 FEBRUARY 2023: GMK-SPHERE 02.12.1002L FEMORAL COMPONENT SPHERE CEMENTLESS SIZE 2 L LOT. 1810121 (ITEM NOT REGISTERED IN USA). LOT 1810121: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2019. EXPIRATION DATE: 2024-04-08. 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. GMK-SPHERE 02.12.0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L (K121416) LOT. 2010581 LOT 2010581: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2020. EXPIRATION DATE: 2025-11-26. 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

    REVISION SURGERY AT ABOUT 1 YEAR AND 8 MONTHS AFTER PRIMARY FOR KNEE STIFFNESS AND PATELLOFEMORAL PAIN. THE SURGEON REVISED ALL THE DEVICES SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922104 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L TIBIAL TRAY FIXED JWH MEDACTA INTERNATIONAL SA 02.07.1202L 2102494 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention