BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE 02.18.004RM ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM

    MDR report key: 13567347 · Received February 21, 2022

    Report

    Report Number
    3005180920-2022-00139
    Event Type
    Injury
    Date Received
    February 21, 2022
    Date of Event
    January 28, 2022
    Report Date
    February 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895609
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 FEBRUARY 2022: LOT 1908022: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2019. EXPIRATION DATE: 2024-11-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 02 FEBRUARY 2022: MOTO PARTIAL KNEE 02.18.TF5.RM TIBIAL TRAY FIX CEMENTED S5 RM (K162084) LOT 1903771: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2019. EXPIRATION DATE: 2024-10-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.IF5.08.RM TIBIAL INSERT FIX S5 RM - 8MM (K162084) LOT 1903779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JULY-2019. EXPIRATION DATE: 2024-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 FEBRUARY 2022: LOT 1908022: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2019. EXPIRATION DATE: 2024-11-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 02 FEBRUARY 2022: MOTO PARTIAL KNEE 02.18.TF5.RM TIBIAL TRAY FIX CEMENTED S5 RM (K162084) LOT 1903771: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2019. EXPIRATION DATE: 2024-10-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.IF5.08.RM TIBIAL INSERT FIX S5 RM - 8MM (K162084) LOT 1903779: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JULY-2019. EXPIRATION DATE: 2024-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN MENISCUS ON THE LATERAL SIDE AND THE CAUSE IS UNKNOWN. AT 1 YEAR AND 7 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN MENISCUS ON THE LATERAL SIDE AND THE CAUSE IS UNKNOWN. AT 1 YEAR AND 7 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE INSERT, TIBIAL TRAY, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401228 MOTO PARTIAL KNEE 02.18.004RM ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM ANATOMICAL FEMORAL COMPONENT CEMENTED HSX MEDACTA INTERNATIONAL SA 02.18.004RM 1908022 07630030895609

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention