BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R

    MDR report key: 19633343 · Received June 28, 2024

    Report

    Report Number
    3005180920-2024-00462
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 18, 2024
    Report Date
    June 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826580
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 JUNE 2024. LOT 2010599: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2020. EXPIRATION DATE: 2025-11-29. 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

    REVISION SURGERY 7 DAYS AFTER SURGERY. THE PATIENT HAD THE WOUND OPEN, BUT THE REASON OF IT IS UNKNOWN. DURING REVISION THE SURGEON WASHED OUT THE WOUND AND NOTICED THAT THE KNEE WAS UNSTABLE, SO HE DECIDED TO SWAP THE LINER INSERTING A 2MM THICKER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828905 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R KNEE FIXED TIBIAL INSERT FLEX JWH MEDACTA INTERNATIONAL SA 2010599 07630030826580

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention