BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLOC 133 MP SP TP1 PPS HO 5.0

    MDR report key: 2912619 · Received January 13, 2013

    Report

    Report Number
    3002806535-2013-00002
    Event Type
    Injury
    Date Received
    January 13, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    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. NO PRODUCT WAS RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TAPERLOC HIP SURGERY ON (B)(6) 2012. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO PATIENT FALLING AT HOME AND FRACTURING HIP. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19617 TLOC 133 MP SP TP1 PPS HO 5.0 PROSTHESIS, HIP KWA BIOMET UK LTD. N/A 2479037

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R