BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COONRAD/MORREY HUMERAL ASSEMBLY

    MDR report key: 5074091 · Received September 14, 2015

    Report

    Report Number
    1822565-2015-01830
    Event Type
    Injury
    Date Received
    September 14, 2015
    Report Date
    August 20, 2015
    Manufacturer
    ZIMMER INC
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. (B)(4). OTHER DEVICE USED: UNKNOWN COONRAD/MORREY ULNAR ASSEMBLY. 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. IT COULD NOT BE CONFIRMED IF THE DEVICES ARE AN APPROVED AND COMPATIBLE COMBINATION. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. 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. PLEASE REFERENCE LITERATURE AT THE FOLLOWING LOCATION: HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/24906903.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PATIENT EXPERIENCED IRRIGATION AND DEBRIDEMENT DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607817 UNKNOWN COONRAD/MORREY HUMERAL ASSEMBLY ELBOW PROSTHESIS JDC ZIMMER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other