BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.E0611FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L E-CROSS

    MDR report key: 18214613 · Received November 28, 2023

    Report

    Report Number
    3005180920-2023-00926
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    October 29, 2023
    Report Date
    November 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971262270
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 NOVEMBER 2023: LOT 2110597: 25 ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2021. EXPIRATION DATE: 2026-09-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 28 NOVEMBER 2023: LOT 2307827: 110 ITEMS MANUFACTURED AND RELEASED ON 26-JUNE-2023. EXPIRATION DATE: 2028-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 67 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD PAIN DUE TO THE PATELLA TRACKING BEING OFF. AT 1 MONTH FROM PRIMARY THE SURGEON REVISED THE INSERT BECAUSE HE WAS NOT HAPPY WITH HIS FLEXION GAP AND FOR THE PATELLA HE JUST DID A LATERAL RELEASE OF SOFT TISSUE TO SOLVE THE TRACKING PROBLEM. THE PATELLA WAS NOT REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602541 GMK-SPHERE 02.12.E0611FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/11 MM L E-CROSS KNEE TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 2110597 07630971262270

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention