BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R

    MDR report key: 19936760 · Received August 8, 2024

    Report

    Report Number
    3005180920-2024-00625
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 8, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707527
    PMA / PMN Number
    K181635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 JULY 2024. LOT 185623: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2018. EXPIRATION DATE: 2023-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT REVISED. BATCH REVIEW PERFORMED ON 27 JULY 2024 ON GMK-SPHERE 02.12.0411CRL TIBIAL INSERT FIXED SPHERE CR SIZE 4/11 MM L (K181635) LOT. 185589. LOT 185589: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-OCT-2018. EXPIRATION DATE: 2023-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER 2 SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY RIGHT TKA ON (B)(6) 2019 AND HAD A PRIMARY LEFT TKA ON (B)(6) 2019. PRESENTLY ON (B)(6) 2024 THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON PERFORMED A BILATERAL POLY-SWAP, REVISING THE RIGHT S4 12MM SPHERE CR TO A S4 14MM SPHERE E-CROSS AND THE LEFT S4 11MM SPHERE CR TO A S4 14MM SPHERE E-CROSS. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PROBLEMS WERE REPORTED WITH ANY OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065498 GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 185623 07630040707527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention