BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM

    MDR report key: 10263648 · Received July 13, 2020

    Report

    Report Number
    3005180920-2020-00411
    Event Type
    Injury
    Date Received
    July 13, 2020
    Date of Event
    June 16, 2020
    Report Date
    July 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895555
    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 (B)(6) 2020. LOT 174106: 40 ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2017. EXPIRATION DATE: 2022-09-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 33 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED BATCH REVIEWSPERFORMED ON (B)(6) 2020. MOTO PARTIAL KNEE 02.18.IF2.09.LM TIBIAL INSERT FIX S2 LM - 9MM (K162084) LOT 168001: 24 ITEMS MANUFACTURED AND RELEASED ON 24-JAN-2017. EXPIRATION DATE: 2021-12-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.TF2.LM TIBIAL TRAY FIX CEMENTED S2 LM (K162084) LOT 184280: 10 ITEMS MANUFACTURED AND RELEASED ON 07-SEP-2018. EXPIRATION DATE: 2023-08-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 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 OF PAIN IS UNKNOWN. THE SURGEON REVISED ALL IMPLANTS AND CONVERTED THE MOTO KNEE TO A TOTAL KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728018 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 LM KNEE FEMORAL IMPLANT HSX MEDACTA INTERNATIONAL SA 02.18.002LM 174106 07630030895555

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention