BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 3172473 · Received June 17, 2013

    Report

    Report Number
    0001825034-2013-01974
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. BRAND NAME - UNKNOWN. PRODUCT CODE - UNKNOWN. PRODUCT IDENTIFICATION AND EXPIRATION DATE - UNKNOWN. DATE IMPLANTED - UNKNOWN. MANUFACTURE DATE ¿ UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PATIENT¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT PARTIAL KNEE ARTHROPLASTY IN 2009. SUBSEQUENTLY, PATIENT ALLEGES PAIN, INJECTIONS AND HAVING KNEE DRAINED. NO FURTHER INFORMATION HAS BEEN PROVIDED. 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
    274070 UNKNOWN KNEE PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization