BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    MDR report key: 19711183 · Received July 10, 2024

    Report

    Report Number
    3005180920-2024-00496
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 10, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826382
    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 17 JUNE 2024. LOT 171072: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2017. EXPIRATION DATE: 2022-05-14. 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 MILD INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 5 YEARS AND 11 MONTHS POST PRIMARY THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND UPSIZED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040570 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 171072 07630030826382

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention