BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 7309079 · Received March 2, 2018

    Report

    Report Number
    3005180920-2018-00113
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    July 8, 2016
    Report Date
    June 7, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON THE (B)(6) 2018 THE SURGEON IMPLANTED THE FINAL DEVICES SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 FEBRUARY 2018 LOT 162180: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2016. EXPIRATION DATE: 2021-05-16 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. FEMORAL COMPONENT SPHERE CEMENTED SIZE 5+ L REFERENCE 02.12.0025L (K140826) LOT 171021: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JUNE 2017. EXPIRATION DATE: 2022-05-17 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L REFERENCE 02.12.0510FL (K121416) LOT 162167: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 JULY 2016. EXPIRATION DATE: 2021-06-20 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR INFECTION REMOVING ALL THE HARDWARE AND IMPLANTING A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153139 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 162180 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention