BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2091918 · Received May 17, 2011

    Report

    Report Number
    1825034-2011-00391
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    November 29, 2010
    Report Date
    April 22, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. BIOMET ENGINEER EVALUATED THE PROVIDED RADIOGRAPHIC IMAGES AND RELAYED THAT THE IDENTITY OF THE FOREIGN OBJECT COULD NOT BE DETERMINED, ALTHOUGH IT DOES NOT APPEAR TO BE PART OF THE IMPLANT. A REVISION PROCEDURE TO REMOVE AND VERIFY THE FOREIGN BODY HAS NOT BEEN REPORTED TO DATE. THIS REPORT FILED (B)(4), 2011.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL, INCLUDING RADIOGRAPHIC IMAGES AND OPERATIVE NOTES, INDICATED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2010 AND THAT POSTOPERATIVE RADIOGRAPHS TAKEN WEEKS LATER REVEALED A FOREIGN BODY IN THE PATIENT'S KNEE. AS OF THIS DATE, A REVISION PROCEDURE TO REMOVE THE FOREIGN BODY HAS NOT BEEN PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability