BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC PC 15.0MM T1

    MDR report key: 2771301 · Received October 4, 2012

    Report

    Report Number
    3002806535-2012-00292
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    July 19, 2012
    Report Date
    September 4, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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.IMPLANT DATE - UNKNOWN.THIS IS 2 OF 2 MDR REPORTS SUBMITTED FOR THE SAME EVENT. SEE ALSO 3002806535-2012-00291.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE LONDON IMPLANT RETRIEVAL CENTRE THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON AN UNKNOWN DATE. REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2012 ALLEGEDLY DUE TO ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPERLOC PC 15.0MM T1 PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 912483

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R