BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XE

    MDR report key: 19267220 · Received May 8, 2024

    Report

    Report Number
    3005180920-2024-00289
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 26, 2022
    Report Date
    May 8, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809224
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 APRIL 2024. LOT 21C0054: (B)(4) MANUFACTURED AND RELEASED ON 26-OCT-2021. EXPIRATION DATE: 2026-10-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: LINER: VERSAFITCUP CC TRIO 01.26.3644HCT FLAT PE HC LINER Ø 36 / E (K1033529) LOT 2118278: 128 ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2026-12-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT PRIMARY SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT HAS BEEN REVISED THE FIRST TIME BECAUSE OF SURGICAL WOUND ISSUES. CERAMIC BALL HEAD Ø36 SIZE XL AND LINER Ø36/E REVISED SUCCESSFULLY AND THE SURGEON IMPLANTED CERAMIC BALL HEAD (Ø36 SIZE XL) AND PE LINER. ON (B)(6) 2022, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO JOINT LUXATION. BALL HEAD, LINER AND ACETABULAR SHELL HAVE BEEN SUCCESSFULLY REVISED AND VERSAFITCUP DM Ø58MM, LINER DM Ø28/58MM DMI AND COCR BALL HEAD Ø28 SIZE XL (+7) WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757805 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XE HIP FEMORAL HEAD LZO MEDACTA INTERNATIONAL SA 21C0054 07630030809224

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention