BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC OPTION HEAD DIA36

    MDR report key: 3952437 · Received July 23, 2014

    Report

    Report Number
    3002806535-2014-00175
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 27, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP SURGERY ON (B)(6) 2014. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO PAIN AND SUSPECTED INFECTION. NO OBVIOUS INFECTION WAS OBSERVED DURING REVISION. NO FURTHER DETAILS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431040 DELTA CERAMIC OPTION HEAD DIA36 BIOLOX CERAMIC HEAD LZO BIOMET UK LTD. N/A 3022521

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R