BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX CERAMIC HEAD

    MDR report key: 1961062 · Received January 11, 2011

    Report

    Report Number
    3002806535-2011-00009
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    March 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K061312
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT FILED ON (B)(6), 2011.

    Description of Event or Problem · 1

    PATIENT UNDERWENT HIP PROCEDURE ON (B)(6), 2010. REVISION SURGERY WAS PERFORMED ON (B)(6), 2010, DUE TO INFECTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOLOX CERAMIC HEAD LZO BIOMET UK LTD. NA 1805875

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R