BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 23583103 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01152
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809125
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 NOV 2025. BALL HEADS: MECTACER 01.29.201 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S (K112115) LOT: 2431873: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04 DEC 2024. EXPIRATION DATE: 18 NOV 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. LINER: MPACT DM 01.26.2846MHC DOUBLE MOBILITY HC LINER D 28/DMC (K241767) LOT: 2338169: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 DEC 2023. EXPIRATION DATE: 22 NOV 2028. 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. STEM: QUADRA-P COLLARED 01.12.162 QUADRA-P COLLARED STD. SIZE2 (K192827) LOT: 2436254: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 MAY 2025. EXPIRATION DATE: 11 MAY 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. ROOT CAUSE: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

    ONE MONTH AFTER THE PRIMARY SURGERY, THE PATIENT RETURNED DUE TO AN EARLY-STAGE INFECTION OF AN UNKNOWN PATHOGEN. THE SURGEON PERFORMED A WASHOUT AND REPLACED THE STEM, LINER, AND HEAD. THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236437 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S LZO MEDACTA INTERNATIONAL SA 01.29.201 2431873 07630030809125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention