BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19229030 · Received May 2, 2024

    Report

    Report Number
    3005180920-2024-00262
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 2, 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 08 APRIL 2024. LOT 2012776: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAR-2021. EXPIRATION DATE: 2026-02-15. 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

    THE PATIENT HAD ANTERIOR KNEE PAIN AND INSTABILITY AND THE CAUSE WAS UNKNOWN. AT ABOUT 2 YEARS AND 7 MONTHS POST-PRIMARY THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY, IMPLANTING A THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841695 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2012776 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention