BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R

    MDR report key: 18380468 · Received December 21, 2023

    Report

    Report Number
    3005180920-2023-01025
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 21, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040711418
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 DECEMBER 2023. LOT 2204114: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2022. EXPIRATION DATE: 2027-06-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT. BATCH REVIEW PERFORMED ON 05 DECEMBER 2023 ON GMK-SPHERE 02.07.2802R TIBIAL TRAY FIXED CEMENTED SIZE 2 R TINBN COATED (K202684) LOT. 2214171. LOT 2214171: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2022. EXPIRATION DATE: 2027-11-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 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 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL COMPONENT AND TIBIAL TRAY. THE SURGEON REVISED THE FEMORAL COMPONENT, INSERT AND TIBIAL TRAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297670 GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3 R KNEE CEMENTED FEMORAL COMPONENT TINBN COATED JWH MEDACTA INTERNATIONAL SA 2204114 07630040711418

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention