BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER B/F HUMERAL STEM

    MDR report key: 5024834 · Received August 24, 2015

    Report

    Report Number
    1822565-2015-01540
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    June 1, 2006
    Report Date
    July 29, 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). 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.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT EXPERIENCED A "RIC REPAIR" SURGERY DUE TO A ROTATOR CUFF TEAR AND LATERAL AND ANTERIOR SHOULDER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558196 UNKNOWN ZIMMER B/F HUMERAL STEM SHOULDER PROSTHESIS KWR ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention