BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULE HEAD COCRMO

    MDR report key: 1812345 · Received August 16, 2010

    Report

    Report Number
    3002806535-2010-00060
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 20, 2010
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    K911684
    Removal / Correction Number
    NA
    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. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE IN (B)(6) 2009. PATIENT UNDERWENT REVISION SURGERY IN (B)(6) 2010 DUE TO PATIENT INFECTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULE HEAD COCRMO JDI BIOMET UK LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R