BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVENIR MULLER STEM 7 STANDARD

    MDR report key: 3935919 · Received June 27, 2014

    Report

    Report Number
    9613350-2014-03673
    Event Type
    Other
    Date Received
    June 27, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DAMAGED POUCH HAS NOT BEEN RECEIVED FOR INVESTIGATION. THE CAUSE FOR THIS EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. ONCE RECEIVED AND INVESTIGATED AND THE RESULT OF THE INVESTIGATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUTER POUCH OF THE AVENIR MUELLER STEM WAS DAMAGED. DURING SURGERY ON (B)(4) 2014, TO IMPLANT AN AVENIR MUELLER STEM IN THE PT, UPON OPENING THE OUTER POUCH THAT WAS PROTECTING THE INNER POUCH HOLDING THE STEM, IT WAS NOTICED THAT THE OUTER POUCH HAD A HOLE. IT IS UNK IF THIS OCCURRED WHEN SEPARATING THE TWO POUCHES. THERE WAS NO SIGN OF DAMAGE WITH THE INNER POUCH, AND THE STEM WAS STILL IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377779 AVENIR MULLER STEM 7 STANDARD AVENIR MULLER STEM LZO ZIMMER GMBH 4020785

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other