BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S7 RM

    MDR report key: 7951007 · Received October 10, 2018

    Report

    Report Number
    3005180920-2018-00766
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    September 10, 2018
    Report Date
    October 10, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896828
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE 09 OCTOBER 2018: THE PATHOGEN IS NOT AVAILABLE. BATCH REVIEW PERFORMED ON 09 OCTOBER 2018. LOT 167761: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 FEBRUARY 2017. EXPIRATION DATE: 2022-01-24. 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. MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S6 RM REFERENCE 02.18.006RM (K162084). LOT 163690: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 OCTOBER 2016. EXPIRATION DATE: 2021-06-12. 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. MOTO PARTIAL KNEE TIBIAL INSERT FIX S7 RM - 8MM REFERENCE 02.18.IF7.08.RM, (K162084). LOT 167841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 DECEMBER 2016. EXPIRATION DATE: 2021-11-29. 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

    REVISION SURGERY PERFORMED DUE TO INFECTION AFTER ABOUT 2 YEARS FROM PRIMARY. THIS IS THE SECOND REVISION SURGERY DUE TO INFECTION FOR THIS PATIENT. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER AT AN UNKNOWN DATE. ON (B)(6) 2018 THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792802 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S7 RM TIBIAL TRAY FIX CEMENTED HSX MEDACTA INTERNATIONAL SA 167761 07630030896828

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention