BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A RINGLOC LINER

    MDR report key: 2031612 · Received March 23, 2011

    Report

    Report Number
    3002806535-2011-00030
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K002379
    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. DATE OF REPORT/DATE RECEIVED - COMPLAINT WAS ORIGINALLY REPORTED ON (B)(6) 2011, BUT MANUFACTURER WAS NOT KNOWN UNTIL ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011. EXPIRATION DATE - UNKNOWN. THIS REPORT FILED (B)(6), 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6), 1999. PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2011 DUE TO INFECTION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A RINGLOC LINER LPH BIOMET UK LTD. NA 272845

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R