BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19141714 · Received April 19, 2024

    Report

    Report Number
    3005180920-2024-00255
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    March 28, 2024
    Report Date
    April 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    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 4 APRIL 2024: LOT 153537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-OCT-2015. EXPIRATION DATE: 2020-AUG-30. 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 CAME IN REPORTING PAIN. ABOUT 8 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE POLY (FROM 10 TO 13 MM) AND RESURFACED THE NATURAL PATELLA. DURING THE REVISION, IT WAS NOTED THAT A RIGHT INSERT WAS IMPLANTED IN THE LEFT KNEE DURING THE PRIMARY SURGERY. IT IS UNKNOWN HOW THIS OCCURRED AND THE ISSUE WAS ONLY NOTED DURING THE EXPLANTATION OF THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL NOTE: FEMORAL COMPONENT AND TIBIAL TRAY ARE LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1822840 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 153537 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O