BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY

    MDR report key: 4151532 · Received October 3, 2014

    Report

    Report Number
    9614209-2014-00084
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    CORIN MEDICAL, LTD.
    Product Code
    LZO
    PMA / PMN Number
    K093472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT: DEVICE DETAILS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS CANNOT BE REVIEWED AT THIS TIME AS NO DEVICE DETAILS HAVE BEEN PROVIDED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA. HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    TRINITY CUP AND BIOLOX DELTA CERAMIC LINER REVISED AFTER APPROXIMATELY 6 MONTHS DUE TO "EXAGGERATED ANTEVERSION OF THE CUP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618933 TRINITY ACETABULAR HIP SYSTEM LZO CORIN MEDICAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention ASSOCIATED MINIHIP STEM| ASSOCIATED BIOLOX DELTA CERAMIC LINER 36MM