BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 22911273 · Received August 28, 2025

    Report

    Report Number
    3005180920-2025-00780
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809187
    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 04-08-2025. BALL HEADS: MECTACER 01.29.207 MECTACER HEAD BIOLOX DELTA DIA.32 12/14-XL (K112115) LOT 2100267: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-03-2021 EXPIRATION DATE: 2026-04-19. 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. LINER: MPACT 01.32.3239HCT FLAT PE HC LINER Ø32/C (K103721) LOT. 2215495: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-06-2022 EXPIRATION DATE: 2027-08-02. 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. 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

    AT ABOUT 2 YEARS AND 3 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN THAT THE SURGEON DETERMINED WAS DUE TO A DISLOCATION WITH THE CAUSE UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834105 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.32 12/14-XL LZO MEDACTA INTERNATIONAL SA 01.29.207 2100267 07630030809187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention