BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METAL WASHER

    MDR report key: 4092637 · Received September 16, 2014

    Report

    Report Number
    3002806535-2014-00199
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    September 18, 2014
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 EVENT - UNKNOWN, DATE IMPLANTED - UNKNOWN, DATE EXPLANTED - UNKNOWN, MANUFACTURE DATE - UNKNOWN. ITEM IS CURRENTLY UNDER EVALUATION. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    WASHER WAS RETURNED FOR EVALUATION. INVESTIGATION INDICATED THE WASHER WAS SIMILAR TO AN ITEM USED IN THE CONSTRUCTION OF TWO INSTRUMENTS USED IN THE UNITED KINGDOM. THE WASHER WAS REPLACED IN THESE INSTRUMENTS WITH A TUBE IN 2005. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A METAL WASHER WAS FOUND IN THE PATIENT'S X-RAY FOLLOWING A TOTAL KNEE REPLACEMENT PROCEDURE ON AN UNKNOWN DATE. THE ITEM IS USED ON A KNEE IMPACTOR AND WAS SUBSEQUENTLY REMOVED IN A SECOND PROCEDURE PERFORMED ON AN UNKNOWN DATE. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571736 METAL WASHER MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R