BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 LM

    MDR report key: 8560453 · Received April 29, 2019

    Report

    Report Number
    3005180920-2019-00321
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 29, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030896736
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 29 APR 2019: LOT 160685: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29 OCTOBER 2016. EXPIRATION DATE: 2021-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT (MDR 2017-00465). ADDITIONAL IMPLANTS INVOLVED: MOTO PARTIAL KNEE 02.18.003LM ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM (K162084), LOT 167863: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2017. EXPIRATION DATE: 2022-02-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THIS SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.IF3.09.LM TIBIAL INSERT FIX S3 LM - 9MM (K162084), LOT 168007: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JAN-2017. EXPIRATION DATE: 2021-12-12. 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

    REVISION SURGERY PERFORMED AFTER 1 YEAR AND 7 MONTHS FROM THE PRIMARY DUE TO PAIN (THE CAUSE OF PAIN IS UNKNOWN). THE SURGEON REVISED THE MOTO KNEE TO A TOTAL KNEE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355734 MOTO PARTIAL KNEE TIBIAL TRAY FIX CEMENTED S3 LM KNEE CEMENTED TIBIAL TRAY HSX MEDACTA INTERNATIONAL SA 160685 07630030896736

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention