BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R

    MDR report key: 16512787 · Received March 9, 2023

    Report

    Report Number
    3005180920-2023-00135
    Event Type
    Injury
    Date Received
    March 9, 2023
    Date of Event
    February 7, 2023
    Report Date
    March 9, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827143
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 FEBRUARY 2023: LOT 2105438: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUL-2021. EXPIRATION DATE: 2026-JUL-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.0414FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R (K121416) LOT 1902504: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2019. EXPIRATION DATE: 2024-MAY-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0004R FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 R (K1214169) LOT 2110993: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2021. EXPIRATION DATE: 2026-SEP-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0414CRR TIBIAL INSERT FIXED SPHERE CR SIZE 4/14 MM R (K181635) LOT 1902542: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2019. EXPIRATION DATE: 2024-JUN-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: EARLY INFECTION AFTER PRIMARY TKA CAUSED BONE RESORPTION AND LIGAMENT LAXITY. IN THESE CONDITIONS, THE ORIGINAL PROSTHESIS WAS NOT SUITED ANY LONGER AND NEEDED REPLACEMENT WITH A MORE CONSTRAINED DESIGN. INFECTIONS ARE AN UNFORTUNATE ADVERSE EVENT THAT MAY HAPPEN AFTER TOTAL JOINT ARTHROPLASTY, WIDELY DESCRIBED IN LITERATURE, AND IT SHOULD BE REGARDED AS THE ROOT CAUSE OF THIS ADVERSE EVENT. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS PROBLEM. ANALYSIS PERFORMED BY R&D MANAGER: REVISION SURGERY AFTER 1 YEARS FROM PRIMARY IMPLANTATION FOR LOOSENING OF THE IMPLANT DUE TO BONE RESORPTION AND LIGAMENT LAXITY, CAUSED BY INFECTION. A MORE CONSTRAINED DEVICE HAS BEEN IMPLANTED. FROM THE PICTURE OF THE EXPLANTED DEVICES, SOME RESIDUAL CEMENT CAN BE IDENTIFIED ON THE INTERNAL SURFACE OF THE FEMORAL COMPONENT AND TIBIAL TRAY, WHICH SUGGESTS AN ORIGINAL GOOD FIXATION TO THE BONE. INFECTION IS AN UNFORTUNATE ADVERSE EVENT THAT MAY HAPPEN AFTER TKA, THAT SHOULD BE CONSIDERED AS ROOT CAUSE OF ADVERSE EVENT. ACCORDING TO THE PICTURES AT HAND, THERE IS NO REASON TO SUSPECT THAT THE ROOT CAUSE OF THE EVENT IS RELATED TO A FAULTY DEVICE.

    Description of Event or Problem · 0

    THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2022. ON (B)(6) 2022 THE LINER WAS REVISED DUE TO INFECTION (02.12.0414FR LOT. 1902504 REMOVED AND CR 02.12.0414CRR LOT. 1902542 IMPLANTED). ON (B)(6) 2023 ALL COMPONENTS WERE REVISED AND HINGE SYSTEM IMPLANTED. THE INFECTION WAS ALREADY HEALED, HOWEVER, THE KNEE WAS UNSTABLE (LIGAMENT LAXITY) DUE TO BONE QUALITY BECAUSE THE INFECTION CAUSED BONE RESORPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626760 GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.T3I4R 2105438 07630030827143

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention