BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM

    MDR report key: 11228573 · Received January 26, 2021

    Report

    Report Number
    3005180920-2021-00071
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    December 28, 2020
    Report Date
    January 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816772
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 8 JANUARY 2021: LOT 186262: 30 ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2018. EXPIRATION DATE: 2023-10-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.2013L FEMUR CEMENTED STD SIZE 3NARROW / LEFT (K122232) LOT. 146097 BATCH REVIEW PERFORMED ON 8 JANUARY 2021: LOT 146097: 35 ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2014. EXPIRATION DATE: 2019-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. ADDITIONAL IMPLANT INVOLVED: GMK-PRIMARY 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L (K090988) LOT. 144883 BATCH REVIEW PERFORMED ON 8 JANUARY 2021: LOT 144883: 24 ITEMS MANUFACTURED AND RELEASED ON 9-SEP-2014. EXPIRATION DATE: 2019-07-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017.

    Description of Event or Problem · 1

    6 MONTHS AFTER THE PREVIOUS REVISION SURGERY PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE 1ST REVISION SURGERY WAS PERFORMED DUE TO PAIN (THE PATIENT HAD A FALL) AND THE LINER 14MM WAS REVISED TO 17 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128458 GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 17 MM FIXED KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0217FUC 186262 07630030816772

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention