BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK 3D METAL TIBIAL TRAY

    MDR report key: 24710790 · Received March 30, 2026

    Report

    Report Number
    3005180920-2026-00232
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MBH
    UDI-DI
    07630345710901
    PMA / PMN Number
    K221850
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06 MARCH 2026. GMK-SPHERIKA 02.12. KA104R GMK SPHERIKA FEMORAL COMPONENT S4R CEMENTLESS (NOT DISTRIBUTED IN US) LOT 2523018: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-NOV-2025. EXPIRATION DATE: 2030-11-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.3D34R GMK 3DMETAL TIBIAL TRAY SIZE T3I4R CEMENTLESS (K090988) LOT 2503266: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-APRIL-2025. EXPIRATION DATE: 2030-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. PATIENT MATCH PLANNING REVIEW. THE ANALYSIS OF THE PROCESS FOUND OUT NO ERRORS: EACH STEP OF THE MYSOLUTIONS PROCESS HAS BEEN PERFORMED CORRECTLY. THE POST-OP VALUES THEY REPORTED IN THE COMPLAINT ARE INDEED DIFFERENT FROM THE ONES PLANNED IN THE VALIDATED REVISION: ON THE TIBIA 8.0° OF VARUS, VERSUS 3.0° OF PLANNED VARUS ON THE FEMUR 10.0° OF VALGUS, VERSUS 4.5° OF PLANNED VALGUS. NEXTAR DATA ANALYSIS. BASED ON THE REVIEW OF THE INTRAOPERATIVE LOGS, THE ALIGNMENT PLANNED AND RECORDED BY THE SYSTEM DURING THE PROCEDURE IS NOT CONSISTENT WITH THE VARUS/VALGUS VALUES OBSERVED IN THE RADIOGRAPHIC ASSESSMENT PERFORMED SIX WEEKS POSTOPERATIVELY. THIS COMPARISON INDICATES THAT THE POSTOPERATIVE MEASUREMENTS DO NOT REFLECT THE INTRAOPERATIVE PLANNING DOCUMENTED IN THE SYSTEM LOGS. THE ROOT CAUSE OF THE MISALIGNMENT REMAINS UNDETERMINED BASED ON THE AVAILABLE INFORMATION. ROOT CAUSE: THE OVERALL ANALYSIS DOES NOT SUGGEST ANY DEVICE- OR TECHNOLOGY-RELATED ROOT CAUSE. THE DISCREPANCY BETWEEN THE PLANNED AND THE POST-OPERATIVE ALIGNMENT VALUES CANNOT BE EXPLAINED BASED ON THE AVAILABLE INTRAOPERATIVE LOGS.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION: BASED ON THE AVAILABLE INFORMATION, THIS CASE REPRESENTS A POSTOPERATIVE MALALIGNMENT FOLLOWING TKA, WITH RADIOGRAPHIC EVIDENCE OF VARUS POSITIONING OF BOTH THE FEMORAL AND TIBIAL COMPONENTS, RESULTING IN A JOINT LINE ORIENTED DISTALLY AND MEDIALLY. HOWEVER, THE RESULTING HKA DOES NOT DIFFER SIGNIFICANTLY FROM THE CONTRALATERAL SIDE. ACCORDING TO THE R&D ANALYSIS OF THE INTRAOPERATIVE LOG FILES, THE ALIGNMENT PLANNED AND RECORDED BY THE NAVIGATION SYSTEM DURING THE PROCEDURE IS NOT CONSISTENT WITH THE POSTOPERATIVE RADIOGRAPHIC FINDINGS. NO EVIDENCE OF DEVICE MALFUNCTION OR DEFECT WAS IDENTIFIED. ONE POSSIBLE EXPLANATION IS THAT THE TRACKER OR CAMERA HOLDER MAY HAVE BEEN INADVERTENTLY DISPLACED DURING SURGERY. HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. THE CLINICAL CONSEQUENCES OF THIS SITUATION ARE UNCERTAIN AND WILL DEPEND ON THE RESULTING JOINT STABILITY AND SOFT TISSUE BALANCE. INTRAOPERATIVELY, THE SURGEON ELECTED TO PLACE AN ANCHOR TO STABILIZE THE MEDIAL COLLATERAL LIGAMENT. ROOT CAUSE: THE OVERALL ANALYSIS DOES NOT SUGGEST ANY DEVICE- OR TECHNOLOGY-RELATED ROOT CAUSE. THE DISCREPANCY BETWEEN THE PLANNED AND THE POST-OPERATIVE ALIGNMENT VALUES CANNOT BE EXPLAINED BASED ON THE AVAILABLE INTRAOPERATIVE LOGS.

    Description of Event or Problem · 0

    IMPLANT MALALIGNMENT WAS IDENTIFIED SIX WEEKS AFTER THE PRIMARY SURGERY. APPROXIMATELY 8° OF VARUS ALIGNMENT OF THE TIBIAL COMPONENT AND 10° OF VALGUS ALIGNMENT OF THE FEMORAL COMPONENT WAS IDENTIFIED. THE PATIENT REPORTS A FLEXION CONTRACTURE. AT THIS TIME, NO REVISION PROCEDURE IS PLANNED. THE PRIMARY WAS PERFORMED USING MYKNEE GUIDES AND NEXTAR. NO INTRA-OPERATIVE OR IMMEDIATE POST-OPERATIVE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122406 GMK 3D METAL TIBIAL TRAY GMK 3DMETAL TIBIAL TRAY SIZE T3I4R CEMENTLESS MBH MEDACTA INTERNATIONAL SA 02.12.3D34R 2523173 07630345710901

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Other