BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    MDR report key: 23579953 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01141
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 28, 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 3 NOVEMBER 2025. BALL HEADS: MECTACER 01.29.201 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S (K112115) LOT 2436086: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JAN-2025. EXPIRATION DATE: 26-DEC-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: VERSAFITCUP DM 01.26.2850MHC DOUBLE MOBILITY HC LINER D 28/DME (K092265) LOT 2428651: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-DEC-2024. EXPIRATION DATE: 05-DEC-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. CUP: MPACT 3D METAL 01.38.056DH MPACT 3D METAL SHELL TWO HOLE D 56MM (K171966) LOT 2109315: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2021. EXPIRATION DATE: 26-JUL-2026. 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. IMPACT 01.32.4248CF DM CONVERTER F/DME - TIN COATED (K211891) LOT. 2310425: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2023. EXPIRATION DATE: 24-OCT-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. OTHER: SCREWS 01.43.0025 CANCELLOUS BONE SCREW D 6,5 L25 (K200391) LOT. 2319119: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2023. EXPIRATION DATE: 26-AUG-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. OTHER: SCREWS 01.43.0025 CANCELLOUS BONE SCREW D 6,5 L25 (K200391) LOT. 2428089: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-DEC-2024. EXPIRATION DATE: 3-DEC-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. 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

    ON (B)(6) 2025, THE PATIENT HAD PRIMARY LEFT HIP SURGERY. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY (MDR (B)(4)). ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE CUP, SCREWS, LINER, DM CONVERTER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316973 MECTACER BIOLOX DELTA FEMORAL BALL HEAD MECTACER HEAD BIOLOX DELTA DIA.28 12/14-S LZO MEDACTA INTERNATIONAL SA 01.29.201 2436086 07630030809125

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention