BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 22384185 · Received July 2, 2025

    Report

    Report Number
    3005180920-2025-00632
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 2, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 JUNE 2025. LOT: 2436092: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23/01/2025. EXPIRATION DATE: 01/01/2030. 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. ADDITIONAL COMPONENTS REVISED: BATCH REVIEW PERFORMED ON 18 JUNE 2025. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT: 2421206: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03/10/2024. EXPIRATION DATE: 12/09/2029. 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. 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 1 MONTH FROM THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN 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
    153236 MECTACER BIOLOX DELTA FEMORAL BALL HEAD FEMORAL HEAD Ø 32 SIZE S LZO MEDACTA INTERNATIONAL SA 01.29.204 2436092 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention