BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FULL-PE UC TIBIAL COMPONENT SIZE 2/14

    MDR report key: 11176899 · Received January 15, 2021

    Report

    Report Number
    3005180920-2021-00047
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 15, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816642
    PMA / PMN Number
    K131310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 JANUARY 2021: LOT 1902012: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-APR-2019. EXPIRATION DATE: 2024-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAS BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 12 JANUARY 2021: GMK-PRIMARY 02.07.2003R FEMUR STD CEMENTED SIZE 3 R (K090988)LOT. 172883: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2017. EXPIRATION DATE: 2022-09-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED WASHOUT AND REVISED THE FULL-PE UC TIBIAL COMPONENT AND FEMORAL COMPONENT, 4 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72883 GMK-PRIMARY FULL-PE UC TIBIAL COMPONENT SIZE 2/14 FULL-PE UC TIBIAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.0214APUC 1902012 07630030816642

    Patients

    Seq Age Sex Outcome Treatment
    1