BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 21855296 · Received April 17, 2025

    Report

    Report Number
    3005180920-2025-00311
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 26, 2025
    Report Date
    April 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    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 31-MARCH-2025: LOT 2416427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-06-2024. EXPIRATION DATE: 2029-06-05. 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 DEVICES INVOLVED: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 2342333: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-12-2023. EXPIRATION DATE: 2028-11-05. 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. MPACT 3D METAL 01.38.050DH MPACT 3D METAL SHELL TWO HOLE Ø50MM (K171966) LOT 2401174: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-02-2024. EXPIRATION DATE: 2029-01-29. 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. 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

    ON THE (B)(6) 2024 THE PATIENT UNDERWENT HIP SURGERY. ON THE (B)(6) 2024 THE SURGEON REVISED THE HEAD DUE TO DISLOCATION OF THE HEAD FROM THE LINER. ON, (B)(6) 2025 THE PATIENT CAME IN REPORTING INSTABILITY AND DISLOCATION. THE SURGEON REVISED CUP, HEAD AND LINER. SURGERY WAS COMPLETED SUCCESSFULLY USING A DOUBLE MOBILITY OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681168 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER MECTACER HEAD BIOLOX DELTA DIA.32 12/14-L LZO MEDACTA INTERNATIONAL SA 01.29.206 2416427 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention