BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2

    MDR report key: 15485483 · Received September 26, 2022

    Report

    Report Number
    3005180920-2022-00729
    Event Type
    Injury
    Date Received
    September 26, 2022
    Date of Event
    August 30, 2022
    Report Date
    September 26, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01-SEP-2022: LOT 2009462: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2020. EXPIRATION DATE: 2025-12-08. 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 THE REVIEW. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 01-SEP-2022: GMK-SPHERE 02.12.0212FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM L (K121416) LOT 2000386: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-12. 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 THE REVIEW. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: FEW WEEKS AFTER PRIMARY CEMENTED TKA THE TIBIAL TRAY IS REPORTED PAINFUL AND FOUND MOBILIZED. THE CASE IS RATHER EXTREME IN TERMS OF ALIGNMENT, BUT THIS CAN HARDLY BE THE PROVEN CAUSE OF THE LOOSENING. SEEING THAT NO CEMENT ADHERED AT ALL TO THE BASEPLATE, WE ARE MORE INCLINED TO ASCRIBE TO A CEMENTATION PROBLEM THE MAIN CAUSE OF MOBILIZATION: FOR EXAMPLE, LIQUID INTERPOSED BETWEEN CEMENT AND TRAY, OR AN UNEXPECTED DELAY IN THE APPOSITION OF CEMENT ON THE UNDERSURFACE OF THE TRAY COULD HAVE CAUSED A SIMILAR EFFECT, AS WELL AS UNEXPECTEDLY HIGH TEMPERATURE OF THE ROOM THAT MAY HAVE HASTENED CURING OF THE CEMENT. WE CANNOT DETERMINE WITH CERTAINTY THE CAUSES OF THIS ADVERSE EVENT WITH THE INFORMATION AT HAND. PRELIMINARY INVESTIGATION PERFORMED BY MEDACTA KNEE PROJECT MANAGER: REVISION SURGERY OF A GMK SPHERE IMPLANT AFTER 1 MONTH AND 3 WEEKS FROM PRIMARY IMPLANTATION DUE TO ASEPTIC LOOSENING. THE INVESTIGATION IS BASED ON THE PICTURE OF THE EXPLANTED TIBIAL TRAY, IN WHICH NO RESIDUAL CEMENT CAN BE NOTED ON THE DISTAL SURFACE OF THE TIBIAL BASEPLATE. POOR INTERDIGITATION BETWEEN CEMENT AND IMPLANT CAN BE RELATED TO MULTIPLE FACTORS, MOST LIKELY NOT IMPLANT RELATED (SUCH AS CEMENTATION PROCESS, TEMPERATURE, TIME, PRESENCE OF FLUIDS ON THE SURFACES OF CEMENT INTERFACE). THE ABSENCE OF CEMENT ON THE DISTAL SURFACE IS NOT EVIDENCE OF A FAULTY DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AND 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF THE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1910821 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1202L 2009462 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention