BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 21320669 · Received February 6, 2025

    Report

    Report Number
    3005180920-2025-00018
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 7, 2025
    Report Date
    February 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862397
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 JANUARY 2025: LOT 2308294: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-23. EXPIRATION DATE: 2028-JUN-21. 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 INVOLVED: BATCH REVIEWS PERFORMED ON 14 JANUARY 2025. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED SIZE 5 L (K090988) LOT 2311079: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-23. EXPIRATION DATE: 2028-AUG-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 02.12.0514FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/14 MM L (K121416) LOT 2202782: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2022. EXPIRATION DATE: 2027-APR-21. 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 AFFARIS DIRECTOR: ONE YEAR AFTER PRIMARY CEMENTED TKA, A LATE INFECTION DEVELOPS AND REVISION IS UNDERTAKEN. THE REPORT DOES MENTION INFECTION, BUT THE GERM IS STILL UNKNOWN. INFECTIONS ARE A POSSIBLE ADVERSE EVENT FOLLOWING TOTAL JOINT REPLACEMENT, WIDELY DESCRIBED IN LITERATURE. NO REASON TO SUSPECT THAT A DEFECTIVE IMPLANT IS AT THE ORIGIN OF THIS EVENT. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION PERFORMED DUE TO INFECTION ABOUT 1 YEAR AND 3 MONTHS AFTER THE PRIMARY SURGERY. ALL COMPONENTS REVISED AND HINGE SYSTEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919830 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L JWH MEDACTA INTERNATIONAL SA 02.12.0024L 2308294 07630030862397

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention