BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

    MDR report key: 12758076 · Received November 7, 2021

    Report

    Report Number
    3005180920-2021-00850
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    October 6, 2021
    Report Date
    November 5, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825859
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 OCTOBER 2021: LOT 1810101: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019. EXPIRATION DATE: 2024-FEB-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: DELAYED INFECTION IN CEMENTED TKA, 1 YEAR AFTER PRIMARY OPERATION. 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 OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 22 OCTOBER 2021: GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX #5/10 MM L (K121416) LOT 189013: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019. EXPIRATION DATE: 2024-FEB-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1205L TIBIAL TRAY FIXED CEMENTED # 5 L (K090988) LOT 1910497: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-MAR-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0035RP PATELLA RESURFACING # 3 (K090988) LOT 1905310: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2019. EXPIRATION DATE: 2024-JUL-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    LEFT KNEE REVISION SURGERY DUE TO INFECTION WAS PERFORMED 1 YEAR AFTER THE PRIMARY SURGERY. HINGE SYSTEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659303 GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0005L 1810101 07630030825859

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other