BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM

    MDR report key: 16061013 · Received December 28, 2022

    Report

    Report Number
    3005180920-2022-00990
    Event Type
    Injury
    Date Received
    December 28, 2022
    Date of Event
    December 20, 2022
    Report Date
    December 28, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895982
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 DECEMBER 2022: LOT 2201828: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APR-2022. EXPIRATION DATE: 2027-03-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS REVISED: MOTO PARTIAL KNEE 02.18.004RM ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM (K162084) LOT. 2207902: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2022. EXPIRATION DATE: 2027-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF3.RM TIBIAL TRAY FIX CEMENTED S3 RM (K162084) LOT. 2201288: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2022. EXPIRATION DATE: 2027-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 1 MONTH POST PRIMARY DUE TO PAIN. THE SURGEON COMMENTED THAT A SLIGHT VARUS OF THE TIBIAL BASEPLATE COULD BE THE CAUSE OF THE PAIN. THERE WAS NO LOOSENING/MOBILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923394 MOTO PARTIAL KNEE TIBIAL INSERT FIX S3 RM - 8MM PARTIAL KNEE TIBIAL INSERT HSX MEDACTA INTERNATIONAL SA 02.18.IF3.08.RM 2201828 07630030895982

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention