BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R

    MDR report key: 14010094 · Received April 5, 2022

    Report

    Report Number
    3005180920-2022-00235
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 5, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819896
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10 MARCH 2022. LOT 1903510: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2019. EXPIRATION DATE:2024-SEP-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS UNKNOWN. THE SURGEON'S PLAN WAS TO RESURFACE THE PATELLA AND POSSIBLY SWAP THE POLY. HOWEVER, DURING SURGERY, HE DECIDED TO CHECK COMPONENTS FOR LOOSENING AND FOUND THE TIBIA TO BE LOOSE. THE SURGEON REVISED THE TIBIAL TRAY AND POLY, AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604137 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R CEMENTED TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1203R 1903510 07630030819896

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention