BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ARCOM 3 POST PATELLA 31MM

    MDR report key: 2120517 · Received June 10, 2011

    Report

    Report Number
    1825034-2011-00483
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    January 18, 2011
    Report Date
    May 16, 2011
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY FORWARDED A REPORT AFTER RECEIVING A FAXED LETTER FROM BIOMET ON (B)(6), 2011 WITH EVENT DETAILS. THIS FOLLOW-UP REPORT IS BEING FILED TO MAKE THE FDA AWARE THAT BOTH THE MANUFACTURER REPORT NUMBER AND ATTACHED USER FACILITY REPORT ARE FOR THE SAME PATIENT, PART NUMBER AND EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. EVALUATION OF THE RETURNED COMPONENT FOUND THE POSTS ARE MISSING; THEY MAY HAVE FRACTURED DURING IMPLANT REMOVAL. THERE IS AN AREA OF WEAR ON THE ARTICULATING SURFACE AND RESIDUE ON THE NON-ARTICULATING SIDE, WHICH COULD BE BONE CEMENT. THE USER FACILITY WAS NOTIFIED OF THE EVENT ON (B)(4), 2011. TO DATE, A RESPONSE HAS NOT BEEN RECEIVED FROM THE USER FACILITY. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6), 2001. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6), 2011 DUE TO PAIN. THE POLYETHYLENE PATELLA WAS REMOVED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ARCOM 3 POST PATELLA 31MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 805140

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R