BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    MDR report key: 19077268 · Received April 10, 2024

    Report

    Report Number
    3005180920-2024-00210
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21-MAR-2024. LOT 2212770: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2022. EXPIRATION DATE: 2027-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER DEVICE INVOLVED: GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT 2212675: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2022. EXPIRATION DATE: 2027-08-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE 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 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING DISCOMFORT DUE TO THE INABILITY TO REACH FULL FLEXION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412358 GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention