BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PFJ SYSTEM

    MDR report key: 25313933 · Received May 28, 2026

    Report

    Report Number
    3005180920-2026-00538
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 14, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630971262522
    PMA / PMN Number
    K213071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 MAY 2026 GMK-REVISION 02.15.E029 MOTO PATELLA E-CROSS D 29 (K213071) LOT: 2421817: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-SEPT-2024. EXPIRATION DATE: 2029-SEPT-02. 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. GMK-REVISION 02.07.0412SCF FIXED TIBIAL INSERT SEMICONSTRAINED S.4 / 12 MM (K103170) LOT: 2116747: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2026-DEC-12. 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. ROOT CAUSE: THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE JOINT STABILITY, AND REVISED THE PATELLA IMPLANT. BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT 1 YEAR AND 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN OVER THE PATELLA KNEE JOINT AND THE CAUSE IS UNKNOWN. THE PATIENT COMPLAINED OF THE PATELLA GETTING CAUGHT IN PS FEMUR NOTCH. LAXITY AND SCAR TISSUE WAS OBSERVED. THERE ARE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MOTO D 29 PATELLA TO A MOTO D 38 PATELLA AND REVISED THE SEMICONSTRAINED 12MM INSERT TO AN INSERT P.S. 14MM S4. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462754 MOTO PFJ SYSTEM MOTO PATELLA E-CROSS Ø29 HSX MEDACTA INTERNATIONAL SA 02.15.E029 2421817 07630971262522

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention