BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5

    MDR report key: 8560452 · Received April 29, 2019

    Report

    Report Number
    3005180920-2019-00322
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 APR 2019: LOT 164903: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2016. EXPIRATION DATE: 2021-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL IMPLANTS INVOLVED: GMK-SPHERE 02.12.0025R FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ R (K140826), LOT 165069: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-OCT-2016. EXPIRATION DATE: 2021-10-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM R (K140826), LOT 144289: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAR-2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY TKA ON (B)(6) 2017. THE PATIENT CAME IN COMPLAINING OF PAIN CAUSED BY A TORN QUAD TENDON AND SUBSEQUENTLY, THE SURGEON REPAIRED THE TORN TENDON AND SWAPPED THE POLY ON (B)(6) 2017. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION (1 YEAR AND 4 MONTHS AFTER THE FIRST REVISION) AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE TIBIAL TRAY, FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355730 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 164903 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention