BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM L

    MDR report key: 20085910 · Received August 28, 2024

    Report

    Report Number
    3005180920-2024-00668
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826214
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 AUG 2024 LOT 1903247: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2019. EXPIRATION DATE: 2024-06-01. 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 3 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (FROM 12 TO 20 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520769 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/14 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1903247 07630030826214

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention