BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAFITCUP CC TRIO ACETABULAR SYSTEM

    MDR report key: 25275478 · Received May 26, 2026

    Report

    Report Number
    3005180920-2026-00451
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030807671
    PMA / PMN Number
    K103352
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 4 MAY 2026: LINER: VERSAFITCUP CC TRIO 01.26.3644HCT FLAT PE HC LINER D 36/E (K120531) LOT: 2526511: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-DEC-2025. EXPIRATION DATE: 2030-NOV-13. 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. BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S (K112115) LOT: 2529452: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-NOV-2025. EXPIRATION DATE: 2030-NOV-13. 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. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE 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

    REVISION SURGERY ON DUE TO HIP LUXATION AT ABOUT 3 MONTHS AFTER PRIMARY SURGERY. LINER AND HEAD REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128565 VERSAFITCUP CC TRIO ACETABULAR SYSTEM FLAT PE HC LINER Ø36/E LZO MEDACTA INTERNATIONAL SA 01.26.3644HCT 2526511 07630030807671

    Patients

    Seq Age Sex Outcome Treatment
    1