BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R

    MDR report key: 19466533 · Received June 5, 2024

    Report

    Report Number
    3005180920-2024-00386
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    May 9, 2024
    Report Date
    June 5, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862540
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14-MAY-2024. LOT 183042: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JUN-2018. EXPIRATION DATE: 2023-06-17. 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 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (11 MM) WITH A THICKER ONE (13 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525077 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 183042 07630030862540

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention