BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX OPTION HEADS

    MDR report key: 23758549 · Received December 9, 2025

    Report

    Report Number
    3005180920-2025-01233
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 9, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809354
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 DECEMBER 2025. BALL HEADS: MECTACER 01.29.233H MECTACER HEAD BIOLOX OPTION 12/14 D40 (K131518) LOT: 2406574: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-APR-2024. EXPIRATION DATE: 19-MAR-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 CUP: MPACT 01.32.156MH ACETABULAR SHELL D 56 MULTI-HOLE (K132879) LOT: 2348587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2024. EXPIRATION DATE: 29-APR-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. LINER: MPACT 01.32.4048HCT FLAT PE HC LINER D 40/F (K103721) LOT: 2306064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2023. EXPIRATION DATE: 10-JUL-2028. 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. STEM: SMS SOLID 01.36.069 SMS SOLID STEM LAT SIZE 9 (K181693) LOT: 2406334: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2024. EXPIRATION DATE: 27-MAR-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. 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

    AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED NEW HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590640 MECTACER BIOLOX OPTION HEADS MECTACER HEAD BIOLOX OPTION 12/14 Ø 40 LZO MEDACTA INTERNATIONAL SA 01.29.233H 2406574 07630030809354

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention