BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 23197950 · Received October 2, 2025

    Report

    Report Number
    3005180920-2025-00850
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 2, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 SEPTEMBER 2025 BALL HEADS: MECTACER 01.29.202 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M (K112115) LOT. 2416420: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUNE-2024. EXPIRATION DATE: 03 JUNE 2029. 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. ADDITIONAL COMPONENT INVOLVED AND REVISED: BATCH REVIEW PERFORMED ON 15 SEPTEMBER 2025 BALL HEADS: MECTACER 01.26.2850MHC DOUBLE MOBILITY HC LINER Ø28/DME (K092265) LOT. 2432636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2025. EXPIRATION DATE: 22-JAN-2030. 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. BATCH REVIEW PERFORMED ON 15 SEPTEMBER 2025 MPACT 01.32.4248CF DM CONVERTER F/DME - TIN COATED (K211891) LOT. 2401180: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUNE-2024. EXPIRATION DATE: 10-JUNE-2029. 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. CONCLUSIONS: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    AFTER 12 DAYS FROM PRIMARY SURGERY, THE PATIENT CAME IN DUE TO AN INFECTION WITH AN UNKNOWN PATHOGEN. THE SURGEON REVISED THE LINER, CONVERTER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278338 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER BIOLOX DELTA FEMORAL BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.202 2416420

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention