BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 22792532 · Received August 13, 2025

    Report

    Report Number
    3005180920-2025-00775
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 2, 2025
    Report Date
    August 13, 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 31 JUL 2025. BALL HEADS: MECTACER 01.29.209 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-M (K112115) LOT 146033: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-DEC-2014. EXPIRATION DATE: 2019-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT AND REVISED: BATCH REVIEW PERFORMED ON 31 JUL 2025. MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G (K103721) LOT. 130419: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAR-2013. EXPIRATION DATE: 2018-02-28. 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

    AT 10 YEARS 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER (FROM Ø36 TO Ø40) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66081 MECTACER BIOLOX DELTA FEMORAL BALL HEAD FEMORAL HEAD Ø 36 SIZE M LZO MEDACTA INTERNATIONAL SA 01.29.209 146033 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention