BEUDAMED
    FDA Adverse Event Other Summary report: N

    EXTREMITIES INSTRUMENT

    MDR report key: 4173771 · Received October 9, 2014

    Report

    Report Number
    9613350-2014-03973
    Event Type
    Other
    Date Received
    October 9, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE INSTRUMENT FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED FOR THE INSTRUMENT, THE INSTRUMENT HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AN UNKNOWN ANATOMICAL SHOULDER ON THE LEFT SIDE ON (B)(6) 2014. DURING IMPLANTATION OF THE ANATOMICAL SHOULDER GLENOID, A GLENOID BONE FRACTURE OCCURRED. IT IS MENTIONED IN THE SURGICAL REPORT THAT THE USED GLENOID REAMER (EXACT CATALOG NUMBER UNKNOWN) UNFORTUNATELY CAUSED THE BONE FRACTURE. IT WAS REPORTED LATER (ON (B)(6) 2014) THAT IT WAS A SMALL PORTION OF GLENOID AND DID NOT AFFECT IMPLANT STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636998 EXTREMITIES INSTRUMENT EXTREMITIES INSTRUMENT LXH ZIMMER GMBH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other