BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 RM

    MDR report key: 18756833 · Received February 22, 2024

    Report

    Report Number
    3005180920-2024-00070
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    January 31, 2024
    Report Date
    February 22, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895562
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 06-FEB-2024 LOT 2215085: 18 ITEMS MANUFACTURED AND RELEASED ON 27-SEP-2022. EXPIRATION DATE: 2027-09-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 06-FEB-2024: MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM (K162084) LOT 2218371: 32 ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2022. EXPIRATION DATE: 2027-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF2.RM TIBIAL TRAY FIX CEMENTED S2 RM (K162084) LOT 2211033: 10 ITEMS MANUFACTURED AND RELEASED ON 31-AUG-2022. EXPIRATION DATE: 2027-08-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED MOTO PARTIAL KNEE SYSTEM TO A GMK-SPHERE SYSTEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62598 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S2 RM KNEE FEMORAL COMPONENT HSX MEDACTA INTERNATIONAL SA 2215085 07630030895562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention