BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT HYBRID GLENOID POST REGENEREX POROUS TITANIUM CONSTRUCT

    MDR report key: 2831677 · Received November 14, 2012

    Report

    Report Number
    0001825034-2012-02417
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    1825034-2012-019R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DECISION WAS MADE TO RECALL BASED ON A MANUFACTURING ISSUE THAT WAS DETERMINED AS PART OF AN INTERNAL INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND IT TO BE OUT OF SPECIFICATION. INVESTIGATION INTO THIS COMPLAINT IS ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT COMPREHENSIVE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2012. DURING THE PROCEDURE, MULTIPLE ATTEMPTS WERE MADE TO SCREW THE POROUS PEG ONTO THE GLENOID BASE WITH NO SUCCESS. A NEW GLENOID BASE AND POROUS PEG WERE OPENED AND USED SUCCESSFULLY TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY AND NO SURGICAL DELAY GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT HYBRID GLENOID POST REGENEREX POROUS TITANIUM CONSTRUCT PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 093780

    Patients

    Seq Age Sex Outcome Treatment
    1