BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER 01.29.207 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE XL

    MDR report key: 14588455 · Received June 3, 2022

    Report

    Report Number
    3005180920-2022-00423
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    May 5, 2022
    Report Date
    June 3, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809187
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11MAY 2022: LOT 163454: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2016. EXPIRATION DATE: 2021-09-21. 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

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. ON (B)(6) 2020, THE SURGEON REVISED THE HEAD AND LINER THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE SURGEON REVISED THE HEAD AND UTILIZED AN OPTION SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755728 MECTACER 01.29.207 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE XL DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.207 163454 07630030809187

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention