BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM L

    MDR report key: 15797475 · Received November 15, 2022

    Report

    Report Number
    3005180920-2022-00858
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040707350
    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 28-OCT-2022: LOT 2112392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-NOV-2021. EXPIRATION DATE: 2026-10-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 28 OCTOBER 2022: GMK-SPHERE 02.12.0311CRL TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM L (K181635) LOT. 1902516. LOT 1902516: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2019. EXPIRATION DATE: 2024-JUN-03. 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.

    Description of Event or Problem · 0

    PRIMARY SURGERY PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2757696 GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 3/11 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0311CRL 2112392 07630040707350

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention