BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MOSAIC STEM

    MDR report key: 3041454 · Received April 8, 2013

    Report

    Report Number
    0001825034-2013-00885
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    April 24, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDC
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE DATE FOR THE REVISION PROCEDURE, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP ARTHROPLASTY APPROXIMATELY A YEAR AND A HALF AGO. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO STEM LOOSENING. THE STEM AND SEGMENT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY APPROXIMATELY A YEAR AND A HALF AGO. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO STEM LOOSENING. THE STEM AND SEGMENT WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP ARTHRIPLASTY APPROXIMATELY A YEAR AND A HALF AGO. SUBSEQUENTLY, SURGEON HAS RECOMMENDED A REVISION PROCEDURE DUE TO STEM LOOSENING. THERE HAS BEEN NO REPORTED REVISION PROCEDURE. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143579 UNKNOWN MOSAIC STEM PROSTHESIS, HIP JDC BIOMET ORTHOPEDICS N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R