BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENT SPHERE CEMENTED SIZE 4

    MDR report key: 18254531 · Received December 4, 2023

    Report

    Report Number
    3005180920-2023-00982
    Event Type
    Injury
    Date Received
    December 4, 2023
    Date of Event
    November 10, 2023
    Report Date
    December 4, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825835
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 NOVEMBER 2023: LOT 2303688: 77 ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2023. EXPIRATION DATE: 2028-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 22 NOVEMBER 2023: GMK-SPHERE 02.12.T3I4L TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L (K121416) LOT. 2303556 LOT 2303556: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUN-2023. EXPIRATION DATE: 2028-05-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0414FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L (K121416) LOT. 2005759 LOT 2005759: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2020. EXPIRATION DATE: 2025-07-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AND A HALF AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593360 FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 CEMENTED FEMEORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2303688 07630030825835

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention