BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 24700709 · Received March 26, 2026

    Report

    Report Number
    3005180920-2026-00241
    Event Type
    Injury
    Date Received
    March 26, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 26, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809149
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09-MAR-2026: BALL HEADS: MECTACER 01.29.203 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L (K112115) LOT 2100261: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2021. EXPIRATION DATE: 2026-APR-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 115 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. LINER: MPACT DM 01.26.2854MHC DOUBLE MOBILITY HC LINER D 28/DMG (K092265) LOT 2103100: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2021. EXPIRATION DATE: 2026-MAY-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 104 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: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 3 YEARS 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DESCRIBING A LEG LENGTH DISCREPANCY ON THE LEFT SIDE AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA OR IMPLANT SUBSIDENCE REPORTED. THE SURGEON REVISED THE D 28 DOUBLE MOBILITY LINER TO A LINER OF THE SAME SIZE AND REVISED THE 28 MM BIOLOX HEAD L WITH A 28 MM BIOLOX OPTION HEAD WITH AND XL SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767035 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.28 12/14-L LZO MEDACTA INTERNATIONAL SA 01.29.203 2100261 07630030809149

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention