BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R

    MDR report key: 8797316 · Received July 17, 2019

    Report

    Report Number
    3005180920-2019-00574
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    June 18, 2019
    Report Date
    July 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826542
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09-JULY-2019: LOT 1811493: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2019. EXPIRATION DATE: 2024-03-20. 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. ADDITIONAL DEVICES INVOLVED IN THE COMPLAINT: BATCH REVIEWS PERFORMED ON 09-JULY-2019: GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416) LOT 179636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2018. EXPIRATION DATE: 2023-03-26. 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 02.12.0005R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R (K121416) LOT 187150: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-19. 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

    6 DAYS AFTER FIRST REVISION SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION, THE PATHOGEN IS UNKNOWN, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, FEMORAL COMPONENT AND TIBIAL TRAY ON (B)(6) 2019. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594412 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 1811493 07630030826542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention