BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 RM - 8MM

    MDR report key: 10122100 · Received June 5, 2020

    Report

    Report Number
    3005180920-2020-00309
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    May 6, 2020
    Report Date
    June 5, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896224
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 18 MAY 2020: LOT 168066: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2017. EXPIRATION DATE: 2021-12-21. 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 ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 18 MAY 2020: MOTO PARTIAL KNEE 02.18.TF5.RM TIBIAL TRAY FIX CEMENTED S5 RM (K162084) LOT. 170796: LOT 170796: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUN-2017. EXPIRATION DATE: 2022-06-07. 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 02.18.004RM ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM (K162084) LOT. 173333: LOT 173333: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2017. EXPIRATION DATE: 2022-10-04. 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

    THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. 6 MONTHS AFTER PRIMARY THE SURGEON REVISED ALL IMPLANTS AND CONVERTED THE PATIENT FROM A PARTIAL KNEE TO A TOTAL KNEE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585810 MOTO PARTIAL KNEE TIBIAL INSERT FIX S5 RM - 8MM TIBIAL INSERT FIXED HSX MEDACTA INTERNATIONAL SA 02.18.IF5.08.RM 168066 07630030896224

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention