BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ L

    MDR report key: 19526290 · Received June 13, 2024

    Report

    Report Number
    3005180920-2024-00414
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 13, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040711562
    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 17 MAY 2024. LOT 2217071: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-DEC-2022. EXPIRATION DATE: 2027-11-28. 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. OTHER DEVICES INVOLVED: GMK-SPHERE 02.12.E0412FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM L E-CROSS (K202022) LOT 2237040: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2022. EXPIRATION DATE: 2027-09-27. 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. GMK-SPHERE 02.07.2804L TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED (K202684) LOT 2239848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MARCH-2023. EXPIRATION DATE: 2028-03-01. 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 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, TIBIAL TRAY AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123575 GMK-SPHERE FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2217071 07630040711562

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention