BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21618973 · Received March 17, 2025

    Report

    Report Number
    3005180920-2025-00189
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 13, 2025
    Report Date
    March 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825811
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13-MAR-2025: LOT 2405939: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APR-2024. EXPIRATION DATE: 09-APR-2029. 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. ADDITIONAL DEVICES REVISED: BATCH REVIEWS PERFORMED ON 13-MAR-2025: GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT 2421610: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-OCT-2024. EXPIRATION DATE: 06-OCT-2029. 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 02.12.0314FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM L (K121416) LOT 2005743: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-SEP-2020. EXPIRATION DATE: 20-AUG-2025. 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 02.07.F11030 PRIMARY EXTENSION STEM Ø11MM / L 30 MM (K133630) LOT 2403247: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-APR-2024. EXPIRATION DATE: 07-APR-2029. 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 MEDACTA MEDICAL AFFAIRS DIRECTOR: FEW DAYS AFTER PRIMARY TKA ON AN OVERWEIGHT LADY PATIENT, A SIGNIFICANT DISLOCATION TAKES PLACE. IT IS LIKELY THAT IT WAS ORIGINATED BY A TRAUMATIC OR QUASI-TRAUMETIC EVENT, THOUGH THE REPORT DOES NOT MENTION IT. SUCH DISLOCATION MEANS THAT AT LEAST ONE OF THE COLLATERAL LIGAMENTS, BUT PROBABLY BOTH, HAVE BEEN DAMAGED OR RUPTURED. IN THESE CONDITIONS, THE CONDYLAR DEVICE USED FOR THE PRIMARY TREATMENT IS NO LONGER INDICATED AND THEREFORE A CONSTRAINED PROSTHESIS MUST BE IMPLANTED. THIS ADVERSE EVENT WAS NOT CAUSED BY A FAULTY OR MALFUNCTIONING DEVICE. BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 8 DAYS AFTER THE PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF LIGAMENT DAMAGE. THE CAUSES ARE UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE IMPLANTS AND IMPLANTED GMK HINGE WITH EXTENSION STEMS. NO ISSUES WITH THE IMPLANTS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566544 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L JWH MEDACTA INTERNATIONAL SA 02.12.0003L 2405939 07630030825811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention