BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 22738117 · Received August 7, 2025

    Report

    Report Number
    3005180920-2025-00745
    Event Type
    Injury
    Date Received
    August 7, 2025
    Date of Event
    July 21, 2025
    Report Date
    August 7, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    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 28 JULY 2025. BALL HEADS: MECTACER 01.29.209 36MM BIOLOX DELTA HEAD M (K112115) LOT. 2500703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2025. EXPIRATION DATE: 15-JAN-2030. 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. ADDIONAL COMPONENT INVOLVED: LINER: MPACT 01.32.3648HC10A FACE CHANG 10° PE HC LINER Ø36/F (K183582) LOT. 2401183: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-FEB-2024. EXPIRATION DATE: 21-JAN-2029. 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. 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

    APPROXIMATELY 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED ONLY THE HEAD, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531702 MECTACER BIOLOX DELTA FEMORAL BALL HEAD FEMORAL HEAD Ø 36 SIZE M LZO MEDACTA INTERNATIONAL SA 01.29.209 2500703 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention