BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOMET ARCOM AP PATELLA

    MDR report key: 853873 · Received May 21, 2007

    Report

    Report Number
    1825034-2007-00066
    Event Type
    Other
    Date Received
    May 21, 2007
    Date of Event
    April 23, 2007
    Report Date
    April 23, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K921182
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 2007. FOLLOWING PLACEMENT OF PATELLA COMPONENT, IT WAS IDENTIFIED THAT THE IMPLANT SIZE WAS SMALL NOT A SIZE MEDIUM AS INDICATED ON THE PROD LABEL. PROD WAS NOT REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ARCOM AP PATELLA JWH BIOMET, INC. NA 379200

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other