BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R

    MDR report key: 15376732 · Received September 8, 2022

    Report

    Report Number
    3005180920-2022-00673
    Event Type
    Injury
    Date Received
    September 8, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862663
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 AUGUST 2022. LOT 2112477: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 2026-SEP-23. 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. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 12 AUGUST 2022. GMK-SPHERE 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R (K121416) LOT 1907918: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2019. EXPIRATION DATE: 2024-OCT-29. 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 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT 1909672: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-DEC-2019. EXPIRATION DATE: 2024-NOV-30. 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 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT 1908642: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2020. EXPIRATION DATE: 2025-FEB-19. 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 HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2022, THE PATIENT CAME DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325595 GMK-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0511FR 2112477 07630030862663

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention