BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 20405452 · Received October 9, 2024

    Report

    Report Number
    3005180920-2024-00803
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 11, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819957
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18-SEP-2024 GMK-SPHERE 02.07.1206R TIBIAL TRAY FIXED CEMENTED SIZE 6 R LOT 2212549: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2022. EXPIRATION DATE: 2027-09-14. 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 COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 18-SEP-2024 GMK-SPHERE 02.12.0006R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R (K121416 ) LOT 2242902: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2023. EXPIRATION DATE: 2027-12-21. 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. BATCH REVIEW PERFORMED ON 18-SEP-2024 GMK-SPHERE 02.12.E004RP PATELLA RESURFACING SIZE 4 E-CROSS (K202022) LOT 2218672: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2022. EXPIRATION DATE: 2027-10-05. 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. BATCH REVIEW PERFORMED ON 18-SEP-2024 GMK-SPHERE 02.12.E0614FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/14 MM R E-CROSS (K202022) LOT 2212183: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2022. EXPIRATION DATE: 2027-07-10. 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.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729243 GMK PRIMARY TOTAL KNEE SYSTEM KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1206R 2212549 07630030819957

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention