BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 23179116 · Received September 30, 2025

    Report

    Report Number
    3005180920-2025-00918
    Event Type
    Malfunction
    Date Received
    September 30, 2025
    Date of Event
    September 2, 2025
    Report Date
    December 22, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809262
    PMA / PMN Number
    K112115
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 DECEMBER 2025 BALL HEADS: MECTACER 01.29.215 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8 (K112115) LOT 2218785: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-NOV-2022. EXPIRATION DATE: 2027-10-13. 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. LINER: MPACT 01.32.4052HCT FLAT PE HC LINER Ø40/G (K122641) LOT 2215506: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2022. EXPIRATION DATE: 2027-08-21. 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. CORRECTION: D1, D2, D4, G4, H4.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 SEPTEMBER 2025: LOT 2254377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-AUG-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION: THE PERFORMED ANALYSIS CONFIRMED THAT THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET HAS BEEN DISASSEMBLED FROM THE MAIN BODY DURING TRIAL REMOVAL FROM THE BONE. DURING EXTRACTION OF THE SYSTEM CONSISTING OF EXTENSION STEM, TRIAL OFFSET AND TRIAL KEEL ASSEMBLY FROM THE BONE, THE ELASTIC CLIPPING OF THE THREADED INSERT OF THE TRIAL OFFSET IS UNABLE TO WITHSTAND THE BLOWS AND DISENGAGES FROM THE OFFSET BODY ITSELF. A NEW MODIFICATION REQUEST HAS BEEN OPENED AND MANAGED TO IMPROVE THE LOCKING SYSTEM BETWEEN THE TWO COMPONENTS OF THE TRIAL OFFSET. ADDITIONAL IMPROVEMENT HAS BEEN MADE ON THE DESIGN AND PRODUCTION PROCESS IN ORDER TO OBTAIN THE ANTIROTATIONAL FEATURE MONOBLOCK WITH THE MAIN BODY INSTEAD OF TWO DIFFERENT COMPONENTS. CONCLUSION: THE ISSUE WAS LIKELY INFLUENCED BY A COMBINATION OF THE INHERENT MECHANICAL LIMITATIONS OF THE DESIGN VERSION INVOLVED AND THE FORCES APPLIED UNDER THE SPECIFIC CONDITIONS OF USE.

    Description of Event or Problem · 0

    THE ANTIROTATIONAL INSERT OF THE TRIAL OFFSET 5MM BROKE. BROKEN PART RETRIEVED AND SURGERY COMPLETED SUCCESSFULLY. APPROXIMATELY 45 MINUTES OF DELAY OCCURRED TO REMOVE THE BROKEN PART. THE SURGEON HAD TO BURR AROUND THE SITE TO GET ACCESS WITH A TRAUMA-THREADED REMOVAL TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014802 MECTACER BIOLOX DELTA FEMORAL BALL HEAD BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL +8 LZO MEDACTA INTERNATIONAL SA 01.29.215 2218785 07630030809262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other