BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

    MDR report key: 10331236 · Received July 28, 2020

    Report

    Report Number
    3005180920-2020-00458
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 2, 2020
    Report Date
    January 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826610
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, THE SURGEON REMOVED THE MEDACTA FEMUR AND INSERT AND IMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 14-JULY-2020. LOT 1903256: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2019. EXPIRATION DATE: 2024-06-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED # 5 L LOT. 180953 (K121416). BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 14-JULY-2020. LOT 180953: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2018. EXPIRATION DATE: 2023-05-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED # 4 L LOT. 181932 (K090988). BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 14-JULY-2020. LOT 181932: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JULY-2018. EXPIRATION DATE: 2023-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0035RP PATELLA RESURFACING # 3 LOT. 182022 (K090988). BATCH REVIEW PERFORMED BY MEDACTA REGUALTORY AFFAIRS DEPARTMENT ON 14-JULY-2020. LOT 182022: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JULY-2018. EXPIRATION DATE: 2023-07-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    5 MONTHS AFTER THE PREVIOUS REVISION SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A MEDACTA FEMUR AND INSERT WITH ANTIBIOTIC CEMENT AS AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800296 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0414FL 18108731903256 07630030826610

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention