BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX OPTION HEADS

    MDR report key: 23232145 · Received October 7, 2025

    Report

    Report Number
    3005180920-2025-00940
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 7, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 SEPT 2025. BALL HEADS: MECTACER 01.29.230H MECTACER HEAD BIOLOX OPTION 12/14 Ø 28 (K131518) LOT 2435458: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JAN-2025. EXPIRATION DATE: 15-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: VERSACEM 01.27.50CMB VERSACEM METALBACK Ø50 MM (K241767) LOT 2423693: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2025. EXPIRATION DATE: 2030-JAN-19. 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 Ø28/DME (K092265) LOT 2343971: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2024. EXPIRATION DATE: 2028-DEC-26. 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. AMIS-K 01.20.212 AMIS-K LONG SIZE 4S1 LENGTH 200MM (K220405) LOT 2405317: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUN-2024. EXPIRATION DATE: 2029-MAY-14. 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. CONCLUSIONS: 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

    AT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747322 MECTACER BIOLOX OPTION HEADS MECTACER HEAD BIOLOX OPTION 12/14 Ø 28 LZO MEDACTA INTERNATIONAL SA 01.29.230H 2435458

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention