BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    MDR report key: 8924582 · Received August 23, 2019

    Report

    Report Number
    3005180920-2019-00697
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    July 24, 2019
    Report Date
    November 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 22-OCTOBER-2019, WE BECAME AWARE THAT REVISION SURGERY HAS NOT BEEN SCHEDULED.

    Description of Event or Problem · 0

    ABOUT 2 YEARS AND 8 MONTHS AFTER PRIMARY REVISION SURGERY NECESSARY FOR TIBIAL TRAY ASEPTIC LOOSENING. NO REVISION SURGERY HAS BEEN SCHEDULED AT THIS TIME. THE AGENT HAS ASKED THE SURGEON MANY TIMES ABOUT THE REVISION SURGERY. THE SURGEON DOES NOT HAVE PLANS TO REVISE THE PATIENT AND DOES NOT HAVE THE PATIENT SCHEDULED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019: LOT 161483: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND 8 MONTHS AFTER PRIMARY REVISION SURGERY NECESSARY FOR TIBIAL TRAY ASEPTIC LOOSENING. NO REVISION SURGERY HAS BEEN SCHEDULED AT THIS TIME. MORE DETAILS TO FOLLOW ONCE THE CASE HAS BEEN SCHEDULED AND COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719313 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 161483 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention