BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX OPTION HEADS

    MDR report key: 25123172 · Received May 8, 2026

    Report

    Report Number
    3005180920-2026-00390
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 8, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809323
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 MAY 2026 STEM: M-VIZION 01.22.427 PROXIMAL BODY D 24MM L 40MM LAT WITH HOLES (K201471) LOT: 2407737: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2024. EXPIRATION DATE: 2029-09-09. 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 01.29.243A MECTACER SLEEVE 12/14 SIZE XL (K131518) LOT: 2527384: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-NOV-2025. EXPIRATION DATE: 2030-10-20. 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 01.29.230H MECTACER HEAD BIOLOX OPTION 12/14 D 28 (K131518) LOT: 2410989: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2024. EXPIRATION DATE: 2029-04-16. 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. STEM: M-VIZION 01.22.103 DISTAL STEM D 14MM L 140MM STRAIGHT (K170690) LOT: 2318726: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JAN-2024. EXPIRATION DATE: 2029-01-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: 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

    PRIMARY SURGERY (DATE UNKNOWN) THE PATIENT INITIALLY UNDERWENT PRIMARY HIP ARTHROPLASTY WITH COMPETITOR IMPLANTS. ON (B)(6) 2024, THE PATIENT PRESENTED WITH SIGNS OF INFECTION (UNKNOWN PATHOGEN). ALL COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT UNDERWENT REVISION SURGERY WITH REPLACEMENT OF ANTIBIOTIC SPACERS. ON (B)(6) 2024, THE SPACERS WERE REMOVED WITH IMPLANTATION OF A MEDACTA DISTAL STEM AND PROXIMAL BODY. ON (B)(6) 2024 (MDR: (B)(4), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE PROXIMAL BODY. ON (B)(6) 2025 (MDR: (B)(4), THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE PROXIMAL BODY. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO AN ACUTE INFECTION. THE SURGEON PERFORMED WASH-OUT AND IMPLANTED A PERMANENT MEDACTA HEAD WITH SLEEVE AND REVISED THE PROXIMAL BODY. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO CHRONIC INFECTION, ALL MEDACTA AND COMPETITOR COMPONENTS WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED. SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2026, THE PATIENT PRESENTED WITH PAIN DUE TO DISLOCATION OF THE HEAD FROM THE LINER WHILE SLEEPING, WITHOUT TRAUMA. THE HEAD AND LINER (ANTIBIOTIC SPACER) WERE REVISED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118051 MECTACER BIOLOX OPTION HEADS MECTACER HEAD BIOLOX OPTION 12/14 Ø 28 LZO MEDACTA INTERNATIONAL SA 01.29.230H 2410989 07630030809323

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention