BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L

    MDR report key: 16618608 · Received March 27, 2023

    Report

    Report Number
    3005180920-2023-00189
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    February 28, 2023
    Report Date
    March 27, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862472
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 MARCH 2023: LOT 2112914: (B)(4) MANUFACTURED AND RELEASED ON 06-DEC-2021. EXPIRATION DATE: 2026-11-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4). OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: EARLY INFECTION IN A TKA, 10 MONTHS AFTER PRIMARY SURGERY. ALL DEVICES WERE REVISED SUCCESSFULLY. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING EVERY SURGERY, INCLUDING TKA'S. TO DATE, THERE IS NO REASON TO SUSPECT THAT THE CAUSE MAY BE LINKED TO THE IMPLANTED DEVICES. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 07 MARCH 2023: GMK-SPHERE 02.12.0311CRL TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM L (K181635) LOT. 2110326 LOT 2110326: (B)(4) MANUFACTURED AND RELEASED ON 16-SEP-2021. EXPIRATION DATE: 2026-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-SPHERE 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT. 2114756 LOT 2114756: (B)(4) MANUFACTURED AND RELEASED ON 08-FEB-2022. EXPIRATION DATE: 2027-01-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR KNEE INFECTION AT ABOUT 10 MONTHS FROM PRIMARY SURGERY. ALL DEVICES WERE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836358 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0022L 2112914 07630030862472

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention