BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PFJ SYSTEM

    MDR report key: 23189760 · Received October 1, 2025

    Report

    Report Number
    3005180920-2025-00975
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 1, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    PMA / PMN Number
    K213071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 SEPT 2025: MOTO PARTIAL KNEE 02.15.E029 MOTO PATELLA E-CROSS Ø29 (K213071) LOT. 2313305: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 OCT 2023. EXPIRATION DATE: 24 SEPT 2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSION: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY KNEE ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AFTER 1 YEAR AND 2 MONTHS, THE PATIENT PRESENTED WITH PAIN OF UNKNOWN CAUSE. THE SURGEON DIAGNOSED A LOOSE PATELLA AND REVISED THE KNEE FROM PARTIAL TO TOTAL KNEE REPLACEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155553 MOTO PFJ SYSTEM MOTO E-CROSS PATELLA D29 HSX MEDACTA INTERNATIONAL SA 02.15.E029 2313305

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention