BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN TM REVERSE SHOULDER GLENOSPHERE

    MDR report key: 5346630 · Received January 6, 2016

    Report

    Report Number
    1822565-2016-00016
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Report Date
    December 9, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    KWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATALOG#UNK, UNKNOWN TM REVERSE SHOULDER BASE PLATE, LOT #UNK. OPERATIVE NOTES WERE REQUESTED HOWEVER NONE PROVIDED. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. 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. ZIMMER-(B)(4) HAS NOT CONFIRMED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE PACKAGING INSERT. 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 (B)(4) CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED A PATIENT WAS IMPLANTED WITH A NON-COMPATIBLE COMBINATION OF ZIMMER BIOMET TRABECULAR METAL REVERSE SYSTEM AND A COMPETITOR'S COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6630 UNKNOWN TM REVERSE SHOULDER GLENOSPHERE SHOULDER PROSTHESIS KWR ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1