BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX CERAMIC HEAD

    MDR report key: 2172604 · Received July 19, 2011

    Report

    Report Number
    3002806535-2011-00105
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K061312
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. SURGEON INDICATED THAT HE HAD IMPLANTED A 32MM CERAMIC LINER WITH A 36MM CERAMIC HEAD. ERROR WAS NOT PICKED UP IN POST-OPERATIVE X-RAYS. EXPLANTED CERAMIC HEAD WAS DISCARDED BY THE HOSPITAL. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    PT UNDERWENT HIP PROCEDURE ON (B)(6), 2011. REVISION SURGERY WAS PERFORMED ON (B)(6), 2011 DUE TO SQUEAKING. SURGEON INDICATED THAT HE HAD IMPLANTED A 32MM CERAMIC LINER WITH A 36MM CERAMIC HEAD. ERROR WAS NOT PICKED UP IN POST-OPERATIVE X-RAYS. EXPLANTED CERAMIC HEAD WAS DISCARDED BY THE HOSPITAL. 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 2197918

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R