BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM CONSTRAINED TIBIAL BEARING 10X79/83

    MDR report key: 3140659 · Received May 31, 2013

    Report

    Report Number
    0001825034-2013-01732
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK833921
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2002. A SUBSEQUENT REVISION WAS PERFORMED (B)(6) 2013 DUE TO INFECTION. THE PATIENT'S KNEE WAS WASHED OUT AND THE BEARING WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241353 MAXIM CONSTRAINED TIBIAL BEARING 10X79/83 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 199390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R