BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20974732 · Received December 19, 2024

    Report

    Report Number
    3005180920-2024-01080
    Event Type
    Injury
    Date Received
    December 19, 2024
    Date of Event
    November 28, 2024
    Report Date
    December 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 DECEMBER 2024 LOT 2002133: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2020. EXPIRATION DATE: 05-13-2025. 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. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. FEW WEEKS AFTER PRIMARY UNCEMENTED TKA, AN INFECTION OCCURS AND THE IMPLANTS MUST BE REMOVED. NO REASON TO SUSPECT A DEFECTIVE DEVICE AT THE ORIGIN OF THIS ADVERSE EVENT. ADDITIONAL IMPLANTS REVISED BATCH REVIEW PERFORMED ON 05 DECEMBER 2024 ON GMK-SPHERE 02.12.1006L FEMORAL COMPONENT SPHERE CEMENTLESS SIZE 6 L LOT. 2243878 (PRODUCT NOT MARKETED IN US) LOT 2243878: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2023. EXPIRATION DATE: 2028-02-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 05 DECEMBER 2024 ON GMK-SPHERE 02.12.3D05L 3DMETAL TIBIAL TRAY SIZE 5L (K221850) LOT. 2311631 LOT 2311631: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2023. EXPIRATION DATE: 2028-09-17. 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. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION OF THE KNEE FOR INFECTION. ALL COMPONENTS WERE REVISED AT ABOUT 1 MONTH POST PRIMARY. THE PATHOGEN IS UNKNOWN. GMK HINGE IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098986 GMK SPHERE TOTAL KNEE SYSTEM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0513CRL 2002133

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention