BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 18516284 · Received January 16, 2024

    Report

    Report Number
    3005180920-2023-01118
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    December 23, 2023
    Report Date
    January 16, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 JANUARY 2024: LOT 2203625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUL-2022. EXPIRATION DATE: 2027-07-07. 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. ADDITIONAL COMPONENT INVOLVED: BATCH REVIEW PERFORMED ON 02 JANUARY 2024: GMK-SPHERE 02.12.0026L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6+ L (K140826) LOT 2201188: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2022. EXPIRATION DATE: 2027-APR-06. 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.E0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L E-CROSS (K202022) LOT 2218638: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEPT-2022. EXPIRATION DATE: 2027-AUG-31. 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.E003RP PATELLA RESURFACING SIZE 3 E-CROSS (K202022) LOT 2218671: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2022. EXPIRATION DATE: 2027-OCT-05. 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.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677231 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2203625 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention