BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L

    MDR report key: 19605555 · Received June 25, 2024

    Report

    Report Number
    3005180920-2024-00482
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 JUNE 2024: LOT 1909756: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MARCH-2020. EXPIRATION DATE: 2025-03-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON 12 JUNE 2024: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 2111802: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2021. EXPIRATION DATE: 2026-08-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS 4 MONTHS 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480992 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 1909756 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention