BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIGLIANI/FLATOW GLENOID COMPONENT

    MDR report key: 5091816 · Received September 21, 2015

    Report

    Report Number
    1822565-2015-01940
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    September 16, 2005
    Report Date
    August 25, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #UNKNOWN, UNKNOWN BIGLIANI/FLATOW HUMERAL HEAD, LOT #UNKNOWN. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE PROVIDED OPERATIVE NOTES ARE VAGUE, AS SUCH; NO DEFINITIVE STATEMENTS CAN BE MADE REGARDING THE SURGICAL TECHNIQUE. NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. THE PART AND LOT NUMBERS OF THE PRODUCT ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THESE PRODUCTS WERE USED FOR TREATMENT. THE COMPLAINT HISTORY FOR THESE PRODUCTS COULD NOT BE REVIEWED DUE TO THE LACK OF LOT NUMBERS. IT COULD NOT BE CONFIRMED IF THE DEVICES ARE AN APPROVED AND COMPATIBLE COMBINATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT WAS REVISED DUE TO THE DISLOCATION. IT IS STATED THAT THE PATIENT HAD A STROKE ON (B)(6) 2005. FOLLOWING THE STROKE, HE EXPERIENCED A DECREASE IN STRENGTH AND RANGE OF MOTION IN HIS SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622714 UNKNOWN BIGLIANI/FLATOW GLENOID COMPONENT SHOULDER PROSTHESIS KWR ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention