BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S

    MDR report key: 16565620 · Received March 17, 2023

    Report

    Report Number
    3005180920-2023-00147
    Event Type
    Injury
    Date Received
    March 17, 2023
    Date of Event
    February 16, 2023
    Report Date
    March 17, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809156
    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 20 FEBRUARY 2023, LOT 2010623: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2021. EXPIRATION DATE: 2026-01-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON 20 FEBRUARY 2023 ON LINER: VERSAFITCUP CC TRIO 01.26.3239HCT FLAT PE HC LINER Ø 32 / C (K120531) LOT. 2011788. LOT 2011788: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-DEC-2020. EXPIRATION DATE: 2025-12-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558258 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.204 2010623 07630030809156

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention