BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 17255320 · Received July 5, 2023

    Report

    Report Number
    3005180920-2023-00495
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    June 2, 2023
    Report Date
    July 5, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2213699: 10 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2022. EXPIRATION DATE: 2027-JUL-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT 2108281: 144 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-SEP-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 141 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0004L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L (K121416) LOT 2108311: 30 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-AUG-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 29 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 PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN 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) 2023, THE PATIENT CAME IN REPORTING STIFFNESS IN THE KNEE DUE TO ARTHROFIBROSIS AND THE CAUSE OF THE ARTHROFIBROSIS IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776048 GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0410FL 2213699 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention