BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 32/+3MM T1

    MDR report key: 5812017 · Received July 21, 2016

    Report

    Report Number
    3002806535-2016-00576
    Event Type
    Injury
    Date Received
    July 21, 2016
    Report Date
    June 21, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EXPIRATION DATE - NI. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET UNITED STATES, HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET IN (B)(4), IN MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K051411. MANUFACTURE DATE ¿ NI.

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY REPORTED EXPERIENCING PAIN IN RIGHT SIDE ANTERIOR SUPERIOR ILIAC SPINE AND IN GRACILIS MUSCLE. PATIENT WAS TREATED WITH MEDICATION AND NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465132 DELTA CER FEM HD 32/+3MM T1 PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2015010971

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention