BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED

    MDR report key: 20244319 · Received September 18, 2024

    Report

    Report Number
    3005180920-2024-00760
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821820
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 SEPTEMBER 2024 LOT 2313968: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2023. EXPIRATION DATE: 2028-10-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: GMK-SPHERE 02.12.0724L FEMORAL COMPONENT SPHERE TINBN COATED SIZE 4+ L (K202684) LOT 2309276: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2023. EXPIRATION DATE: 2028-08-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.E0413FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM L E-CROSS (K202022) LOT 2335816: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-SEP-2023. EXPIRATION DATE: 2028-09-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343513 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L TINBN COATED KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 2313968 07630030821820

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention