BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19642080 · Received July 1, 2024

    Report

    Report Number
    3005180920-2024-00484
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 1, 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 13 JUNE 2024: LOT 2107485: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2021. EXPIRATION DATE: 2026-09-07. 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 DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 13 JUNE 2024: LINER: MPACT 01.32.3241HC10A FACE-CHANGING 10° PE HC LINER Ø32/D (K183582) LOT 2247614: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-FEB-2023. EXPIRATION DATE: 2028-01-27. 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 10 DAYS 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 AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184913 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 2107485 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention