BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R TINBN COATED

    MDR report key: 16157643 · Received January 13, 2023

    Report

    Report Number
    3005180920-2022-00989
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 17, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821837
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 JANUARY 2023: LOT 174148: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2017. EXPIRATION DATE: 2022-11-26. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 9 MONTHS AFTER PRIMARY CEMENTED TKA, THE PATIENT DEVELOPS ARTICVULAR INSTABILITY AND THEREFORE EXCHANGE TO A CONSTRAINED DEVICE IS UNDERTAKEN. THIS IS NORMAL DISEASE PROGRESSION AND THERE IS NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THE REVISION SURGERY. THE REPORT MENTIONS THE ABSENCE OF CEMENT ADHESION TO THE BASEPLATE: THIS IS DUE TO CEMENTATION PROBLEMS, SUCH AS LATE APPLICATION OF THE CEMENT TO THE METAL BASEPLATE, OR POSSIBLY HUMIDITY ON THE SURFACE, OR TEMPERATURE IN THE OR BEING UNEXPECTEDLY HIGHR THAN USUAL: IT IS NOT A PROBLEM TO ASCRIBED TO THE IMPLANTED DEVICES. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 03 JANUARY 2023: GMK-SPHERE 02.12.0412FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R (K121416) LOT. 2005756 LOT 2005756: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-AUG-2020. EXPIRATION DATE: 2025-07-28. 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 02.12.0724R FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ R (K202684) LOT. 2101863. LOT 2101863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2021. EXPIRATION DATE: 2026-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Additional Manufacturer Narrative · 0

    PRELIMINARY INVESTIGATION BASED ON THE PICTURES OF THE EXPLANTED FEMUR AND BASEPLATE: RESIDUAL CEMENT CAN BE SEEN ON THE INTERNAL SURFACE OF THE FEMORAL COMPONENT. NO RESIDUAL CEMENT CAN BE SEEN ON THE EXPLANTED TIBIAL BASEPLATE. ON THE TIBIA SIDE THE CEMENT REMAINED MOST LIKELY ADHERENT TO THE BONE. THIS IS NOT AN EVIDENCE OF INSUFFICIENT ADHESION OF THE CEMENT TO THE BASEPLATE; AND THIS IS THE CASE SINCE THE BASEPLATE WASN'T FOUND LOOSENED. POOR INTERDIGITATION BETWEEN CEMENT AND IMPLANT SURFACE IS MOSTLY INFLUENCED BY MANY FACTORS THAT ARE NOT IMPLANT RELATED (CEMENTATION PROCESS, HUMIDITY ON THE IMPLANT SURFACE, ROOM TEMPERATURE, ETC.).  FROM PRELIMINARY INVESTIGATION, THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    REVISION SURGERY FOR KNEE INSTABILITY DUE LIGAMENT ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON IS SURPRISED THAT THE CEMENT HAS NOT STUCK TO THE TIBIA. COMPETITOR HINGE SYSTEM IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964382 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R TINBN COATED TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.2804R 174148 07630030821837

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention