BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 16917740 · Received May 12, 2023

    Report

    Report Number
    3005180920-2023-00338
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    April 13, 2023
    Report Date
    May 12, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    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 10 MAY 2023. LOT 176243: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2018. EXPIRATION DATE: 2022-DEC-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY R&D MANAGER: REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 5 YEARS FROM PRIMARY IMPLANTATION DUE TO TIBIA SINKING/LOOSENING. FROM VISUAL INSPECTION OF THE EXPLANTED COMPONENTS, WE CAN'T IDENTIFY ANY ANOMALIES RELEVANT TO THE EVENT. THE LATERAL SIDE OF THE TIBIAL INSERT LOOKS WORN OUT ONLY IN THE POSTERIOR PART, SO PROBABLY THE POSITIONING OF THE TIBIAL COMPONENT IN TERMS OF ROTATION WAS SUB-OPTIMAL. WE CAN NOTE ALSO THE COLOR OF THE TIBIAL INSERT TURNED YELLOW IN SOME PORTIONS: THIS IS SOMETHING THAT AFFECTS ONLY THE EXTERNAL SURFACES OF THE INSERT AND IS NOT RELATED TO ABNORMAL OXIDATION OF THE LINER. FROM VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: ABOUT 5 YEARS AFTER PRIMARY CEMENTED TKA, THE TIBIA PLATEAU TILTS BACKWARD AND REQUIRES REVISION SURGERY. FROM THE IMAGES RECEIVED, IT SEEMS THAT THE BONE GAVE WAY AND WAS NOT ABLE TO SUSTAIN THE BASEPLATE ANY LONGER FOR UNKNOWN REASONS. THIS CASE SHOULD BE CLASSIFIED AS ASEPTIC LOOSENING, WHICH IS A POSSIBLE ADVERSE EVENT FOLLOWING TKA, DESCRIBED IN LITERATURE. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0417FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/17 MM L (K121416) LOT 162287: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2016. EXPIRATION DATE: 2021-JUN-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 7 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0025L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L (K140826) LOT 178022: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2018. EXPIRATION DATE: 2022-DEC-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 66 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ABOUT 5 YEARS AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUE TO MALPOSITIONING OF THE TIBIAL TRAY (THE TIBIA HAS TILTED BACKWARD). HINGE SYSTEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475685 GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1204L 176243 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention