BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/14MM

    MDR report key: 16395233 · Received February 17, 2023

    Report

    Report Number
    3005180920-2023-00065
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    January 19, 2023
    Report Date
    February 17, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030818424
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JANUARY 2023: LOT 136098: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2014. EXPIRATION DATE: 2018-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 25 JANUARY 2023: GMK-PRIMARY 02.07.2204R FEMUR PS CEMENTED SIZE 4 R (K090988) LOT. 132483 LOT 132483: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JUL-2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R (K090988) LOT. 150359 LOT 150359: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAR-2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 148620 LOT 148620: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAR-2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 7 YEARS AND 8 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135104 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 5/14MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.07.0514PSF 136098 07630030818424

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention