BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP PROSTHESIS

    MDR report key: 3172743 · Received June 17, 2013

    Report

    Report Number
    3002806535-2013-00105
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    October 21, 2015
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO INFORMATION REGARDING A REVISION PROCEDURE HAS BEEN RECEIVED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. IMPLANT DATE - 2006 (EXACT DATE UNKNOWN). MANUFACTURE DATE - UNKNOWN. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THAT THIS MDR REPORT IS A DUPLICATE OF 1825034-2014-07655.

    Description of Event or Problem · 1

    A POTENTIAL CLAIM WAS RECEIVED BY PATIENT'S LEGAL COUNSEL THAT MEDICAL NEGLIGENCE OCCURRED DURING A HIP REPLACEMENT PROCEDURE IN 2006. NO FURTHER INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274429 UNKNOWN HIP PROSTHESIS PROSTHESIS, HIP LPH BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization