BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL

    MDR report key: 15637257 · Received October 20, 2022

    Report

    Report Number
    3005180920-2022-00792
    Event Type
    Injury
    Date Received
    October 20, 2022
    Date of Event
    September 29, 2022
    Report Date
    October 20, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809262
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 OCTOBER 2022: LOT 1909002: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-FEB-2020. EXPIRATION DATE: 2025-01-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED: BATCH REVIEW PERFORMED ON 05 OCTOBER 2022 ON LINER: MPACT 01.32.4048HCT FLAT PE HC LINER Ø40/F (K122641) LOT. 2103866: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APR-2021. EXPIRATION DATE: 2026-02-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH FROM THE PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147910 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 40 SIZE XL HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.215 1909002 07630030809262

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention