BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 22084131 · Received May 26, 2025

    Report

    Report Number
    3005180920-2025-00453
    Event Type
    Injury
    Date Received
    May 26, 2025
    Date of Event
    April 28, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261518
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D2B HAS BEEN UPDATED FROM JWK TO JWH.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-APR-2025. LOT 2409786: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-05-2024 EXPIRATION DATE: 2029-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 29-APR-2025: GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT. 2317415 LOT 2317415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-10-2023. EXPIRATION DATE: 2028-09-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0022L FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L (K140826) LOT. 2339551 LOT 2339551: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-01-2024. EXPIRATION DATE: 2028-12-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: 5 MONTHS AFTER PRIMARY CMEENTED TKA, THE PATIENT COMPLAINS ABOUT PAIN AND THE SURGEON REPORTS PROBLEMS AT TIBIAL LEVEL, BUT NO SPECIFICATION OF THE PROBLEM WAS SUPPLIED. NO ADDITIONAL SURGERY PERFORMED OR SCHEDULED TO DATE. WITH THE INFORMATION AVAILABLE, NO CLINICAL ANALYSIS OF THE SITUATION CAN BE PERFORMED PROPERLY. ROOT CAUSE: DUE TO THE LACK OF INFORMATION, IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE, WHILE THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 5 MONTHS FROM PRIMARY, DURING A POSTOP APPOINTMENT, THE PATIENT REPORTED PAIN. THE PATIENT SHOWED UNDEFINED COMPLICATION ON THE TIBIA SIDE. CURRENTLY IT IS NOT KNOWN WHETHER A REVISION SURGERY WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331033 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L E-CROSS JWH MEDACTA INTERNATIONAL SA 02.12.E0310FL 2409786 07630971261518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention