BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PATELLA

    MDR report key: 2955663 · Received February 11, 2013

    Report

    Report Number
    0001825034-2013-00259
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-00258 / 00259).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A BILATERAL KNEE ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, PATIENT WAS REVISED IN BOTH KNEES ON (B)(6) 2013, DUE TO PATELLA AND POLY BEARING WEAR. THE POLY BEARINGS AND PATELLAS WERE REMOVED AND REPLACED WITH BIOMET BEARINGS AND PATELLAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59295 UNKNOWN PATELLA PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R