BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L

    MDR report key: 9128596 · Received September 27, 2019

    Report

    Report Number
    3005180920-2019-00812
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 27, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862397
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 2 MONTHS FROM THE LAST REVISION (B)(4) DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER SUCCESSFULLY. ON SEPT 28 THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 05 SEPTEMBER 2019: LOT 181844: 27 ITEMS MANUFACTURED AND RELEASED ON 26-GIU-2018. EXPIRATION DATE: 2023-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 05 SEPTEMBER 2019: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT. 181930 LOT 181930: 86 ITEMS MANUFACTURED AND RELEASED ON 26-GIU-2018. EXPIRATION DATE: 2023-06-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 77 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT. 179657 LOT 179657: 125 ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2018. EXPIRATION DATE: 2023-02-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 118 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 2 MONTHS FROM THE LAST REVISION DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925611 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 181844 07630030862397

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention