BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE

    MDR report key: 3904638 · Received July 1, 2014

    Report

    Report Number
    0001825034-2014-05822
    Event Type
    Injury
    Date Received
    July 1, 2014
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO EVENT DETAILS AND PRODUCT IDENTIFICATION ARE IN PROCESS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, BIOMET WILL FORWARD A SUPPLEMENTAL REPORT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, AN UPCOMING REVISION PROCEDURE HAD BEEN INDICATED FOR AN UNKNOWN REASON. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382551 UNKNOWN KNEE PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R