BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX CERAMIC HEAD

    MDR report key: 1940893 · Received December 23, 2010

    Report

    Report Number
    3002806535-2010-00110
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 8, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K042091
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. THIS REPORT FILED (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6), 2010. NINE WEEKS AFTER SURGERY, THE PATIENT FELL AND AFTER WALKING FOR A FEW DAYS, FELT PAIN. X-RAYS SHOWED A BROKEN CERAMIC HEAD. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2010. 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 2047776

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R