BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 23014742 · Received September 10, 2025

    Report

    Report Number
    3005180920-2025-00828
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825811
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 8 SEPTEMBER 2025: LOT 163331: 33 ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2016. EXPIRATION DATE: 16-JUN-2021. 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. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: THE FEMORAL COMPONENT OF A TOTAL KNEE ARTHROPLASTY (TKA), ALONG WITH THE TIBIAL INSERT, WAS REVISED APPROXIMATELY NINE YEARS AFTER THE PRIMARY IMPLANTATION DUE TO ASEPTIC LOOSENING. THE AVAILABLE RADIOGRAPHIC IMAGES DEMONSTRATE CLEAR RADIOLUCENT LINES, CONSISTENT WITH COMPONENT LOOSENING. ASEPTIC LOOSENING IS A WELL-DOCUMENTED COMPLICATION IN THE LITERATURE, TYPICALLY ASSOCIATED WITH MULTIFACTORIAL OR UNCLEAR ETIOLOGY. IN THIS CASE, THE EXACT CAUSE OF FAILURE CANNOT BE DEFINITIVELY ESTABLISHED BASED ON THE AVAILABLE DATA. HOWEVER, IT IS WORTH NOTING THAT TWO YEARS PRIOR TO THE REVISION, THE PATIENT SUSTAINED A FALL THAT RESULTED IN MOBILIZATION OF THE TIBIAL TRAY, NECESSITATING SURGICAL INTERVENTION. THIS TRAUMATIC EVENT MAY HAVE CONTRIBUTED TO THE FAILURE MECHANISM OBSERVED. ALTHOUGH IT IS NOT POSSIBLE TO IDENTIFY A DEFINITE ROOT CAUSE BASED ON THE AVAILABLE INFORMATION, THE TRAUMATIC EVENT THAT TRIGGERED THE FIRST REVISION MAY ALSO HAVE CONTRIBUTED TO THIS OUTCOME. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2016. ON (B)(6) 2021, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE TIBIAL INSERT SCREW HAD DISENGAGED AND ENDED UP INSIDE OF THE TISSUE. IT WAS ALSO OBSERVED THAT THE TIBIAL INSERT SCREW HAD CAUSED DAMAGE TO THE UNRESURFACED PATELLA. THE SURGEON REVISED THE LINER, TIBIAL TRAY AND ADDED AN EXTENSION STEM AND PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT REPORTING PAIN AFTER FALLING. THE SURGEON OBSERVED THAT THE PATIENT HAD A LOOSE AND SUBSIDED TIBIA. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT. THE SURGERY WAS COMPLETE SUCCESSFULLY. ON (B)(6), 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR AND INSERT (TO AN INSERT OF THE SAME SIZE, PER STANDARD PROCEDURE) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952617 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT CEMENTED - 3R JWH MEDACTA INTERNATIONAL SA 02.12.0003R 163331 07630030825811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention