BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX OPTION HEADS

    MDR report key: 23143568 · Received September 25, 2025

    Report

    Report Number
    3005180920-2025-00904
    Event Type
    Injury
    Date Received
    September 25, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 03 SEPTEMBER 2025: BALL HEADS: MECTACER 01.29.231H MECTACER HEAD BIOLOX OPTION 12/14 Ø 32 (K131518) LOT 2432654: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-FEB-2025. EXPIRATION DATE: 2030-JAN-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 2117198: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-MAR-2022. EXPIRATION DATE: 2027-MAR-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.242A MECTACER SLEEVE 12/14 SIZE L (K131518) LOT 2424221: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2024. EXPIRATION DATE: 2029-09-02. 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: 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

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2025. ON (B)(6) 2024, THE HAD HIP PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) WAS FILED. ON (B)(6) 2025 THE PATIENT HAD SIGNS OF AN HIP INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493565 MECTACER BIOLOX OPTION HEADS MECTACER HEAD BIOLOX OPTION 12/14 Ø 32 LZO MEDACTA INTERNATIONAL SA 01.29.231H 2117198

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention