BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R

    MDR report key: 20300221 · Received September 25, 2024

    Report

    Report Number
    3005180920-2024-00762
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    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 30 AUGUST 2024 LOT 2340762: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2024. EXPIRATION DATE: 2029-01-16. 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 IMPLANTS REVISED: BATCH REVIEW PERFORMED ON 30 AUGUST 2024 ON GMK-SPHERE 02.12.0025R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R (K140826) LOT. 2346324 LOT 2346324: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2024. EXPIRATION DATE: 2029-01-31. 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. BATCH REVIEW PERFORMED ON 30 AUGUST 2024 ON GMK-SPHERE 02.12. E004RP PATELLA RESURFACING SIZE 4 E-CROSS (K202022) LOT. 2346261 LOT 2346261: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2024. EXPIRATION DATE: 2029-01-24. 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 30 AUGUST 2024 ON GMK-SPHERE 02.12. E0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R E-CROSS (K202022) LOT. 2342346 LOT 2342346: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-DEC-2023. EXPIRATION DATE: 2028-12-06. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS FROM THE PRIMARY THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A SPCAER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198785 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R KNEE CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2340762 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention