BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT HYBRID GLEN POST REGENEREX

    MDR report key: 2834421 · Received November 15, 2012

    Report

    Report Number
    0001825034-2012-02425
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 8, 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
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF ANOTHER DEVICE CONFIRMS REPORTED COMPLAINT. INVESTIGATION INTO THE ISSUE IS ONGOING.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2012. DURING THE PROCEDURE THE GLENOID BASE WOULD NO SEAT ONTO THE POROUS PEG. ANOTHER IMPLANT WAS OPENED AND USED TO FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT HYBRID GLEN POST REGENEREX PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 984840

    Patients

    Seq Age Sex Outcome Treatment
    1