BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX OPTION HEADS

    MDR report key: 21320170 · Received February 6, 2025

    Report

    Report Number
    3005180920-2025-00048
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809347
    PMA / PMN Number
    K131518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 22 JANUARY 2025: LOT 2109354: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-NOV-2021. EXPIRATION DATE: 2026-10-07. 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. ADDITIONAL IMPLANTS REVISED: BATCH REVIEWS PERFORMED ON 22 JANUARY 2025 ON LINER: MPACT 01.32.3652HCT FLAT PE HC LINER Ø36/G (K103721) LOT. 2208326 LOT 2208326: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUN-2022. EXPIRATION DATE: 2027-05-30. 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. BATCH REVIEWS PERFORMED ON 22 JANUARY 2025 ON CUP: MPACT 3D METAL 01.38.062DH ACETABULAR SHELL Ø62 TWO-HOLE (K171966) LOT. 2011350 LOT 2011350: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-03-2021. EXPIRATION DATE: 2026-02-22. 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. BATCH REVIEWS PERFORMED ON 22 JANUARY 2025 ON STEM: SMS SOLID 01.36.053 SMS SOLID STEM STD SIZE 13 (K181693) LOT. 2009517 LOT 2009517: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-01-2021. EXPIRATION DATE: 2025-12-21. 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. BATCH REVIEWS PERFORMED ON 22 JANUARY 2025 ON OTHER: SCREWS 01.43.0030 CANCELLOUS BONE SCREW Ø 6,5 L 30 (K200391) LOT. 2208671 LOT 2208671: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-06-2022. EXPIRATION DATE: 2027-05-18. 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. 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

    THE PATIENT HAD SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT 2 YEARS AND 3 MONTHS POST PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918800 MECTACER BIOLOX OPTION HEADS HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.232H 2109354 07630030809347

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention