BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SYSTEM

    MDR report key: 24429829 · Received February 24, 2026

    Report

    Report Number
    3005180920-2026-00146
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    January 14, 2026
    Report Date
    February 24, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807541
    PMA / PMN Number
    K120531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 FEBRUARY 2026 BALL HEADS: MECTACER 01.29.205 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-M (K112115) LOT: 2237479: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-FEB-2022. EXPIRATION DATE: 2027-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. LINER: VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø32/C (K120531) LOT: 2239498: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-NOV-2022. EXPIRATION DATE: 2027-11-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION: 2.5 YEARS AFTER PRIMARY CEMENTLESS THA ON AN ELDERLY LADY, DISLOCATION OCCURS. THE SURGEON REPLACES HEAD AND INSERT, PRESUMABLY BECAUSE THE BONE-CONTACTING COMPONENTS WERE WELL FIXED AND WELL POSITIONED. HE USED A LONGER HEAD TO GIVE ADDITIONAL TENSION AND STABILITY TO THE JOINT. THIS ADVERSE EVENT WAS NOT ORIGINATED BY A FAULTY OF MALFUNCTIONING DEVICE. ROOT CAUSE: DISLOCATION IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT 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

    AT ABOUT 2 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AS THE RESULT OF A DISLOCATION OF THE HEAD AND LINER AND THE CAUSE IS UNKNOWN. NO TRAUMA IS REPORTED. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489758 VERSAFITCUP CC TRIO ACETABULAR SYSTEM FLAT PE HC LINER Ø32/C LZO MEDACTA INTERNATIONAL SA 01.26.3239HCT 2239498 07630030807541

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention