BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L E-CROSS

    MDR report key: 19468102 · Received June 5, 2024

    Report

    Report Number
    3005180920-2024-00382
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    May 7, 2024
    Report Date
    June 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261839
    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 03-JUN-2024. LOT 2119152: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2022. EXPIRATION DATE: 2027-02-22. 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

    AT ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND MINOR INSTABILITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM) WITH A THICKER ONE (14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172216 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L E-CROSS KNEE TIBIAL INSERT E-CROSS JWH MEDACTA INTERNATIONAL SA 2119152 07630971261839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention