BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R E-CROSS

    MDR report key: 18084567 · Received November 7, 2023

    Report

    Report Number
    3005180920-2023-00869
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    October 17, 2023
    Report Date
    November 7, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971261525
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 OCTOBER 2023. LOT 2242217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-01. 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 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PATELLA PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND SWAPPED THE POLY (FROM 10 MM TO 12 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351316 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R E-CROSS KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2242217 07630971261525

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention