BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN COONRAD/MORREY ELBOW IMPLANT

    MDR report key: 2734875 · Received September 5, 2012

    Report

    Report Number
    1822565-2012-01869
    Event Type
    Death
    Date Received
    September 5, 2012
    Report Date
    August 6, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: ZIMMER PREVIOUSLY REPORTED TWO PRIOR PIN REPLACEMENT PROCEDURES FOR THIS PATIENT VIA MDRS IN 2007 AND 2010. NO SPECIFIC DEVICES ARE IDENTIFIED IN THIS CURRENT REPORT. THE STERILIZATION PROCESS FOR ALL DEVICES PRODUCED AT ZIMMER ARE VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10(-6) OR BETTER. THEREFORE, IT IS HIGHLY UNLIKELY THAT A ZIMMER DEVICE CAUSED OR CONTRIBUTED TO ANY PATIENT INFECTION. AS STATED ON THE CENTERS FOR DISEASE CONTROL AND PREVENTION (B)(4) WEBSITE ((B)(4)), "(B)(4) INFECTIONS, AS WITH ALL (B)(4), ARE USUALLY SPREAD BY HAVING CONTACT WITH SOMEONE'S SKIN INFECTION OR PERSONAL ITEMS THEY HAVE USED, LIKE TOWELS, BANDAGES, OR RAZORS THAT TOUCHED THEIR INFECTED SKIN." IN THE TWO PREVIOUS REPORTS, THE PATIENT WAS REPORTED AS HAVING A HIGH ACTIVITY LEVEL. IT IS UNKNOWN WHAT ENVIRONMENT THE PATIENT WAS EXPOSED TO DURING THESE ACTIVITIES. BASED ON THE INFORMATION PROVIDED, AN EXACT CAUSE FOR THE REPORTED INFECTION AND (B)(4) CANNOT BE DETERMINED AT THIS TIME. EVALUATION CODES: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MULTIPLE ELBOW PROCEDURES ON UNKNOWN DATES INCLUDING FAILED COUPLING, REVISIONS OF THE ELBOW ARTHROPLASTY, IMPLANT REMOVAL, MULTIPLE DEBRIDEMENTS, RADICAL JOINT SYNOVECTOMY, ULNAR IMPLANT AND BUSHING REMOVAL, ALL COMPLICATED BY SCAR TISSUE FROM PRIOR PROCEDURES DUE TO THE FAILED DEVICE(S). THE PATIENT WAS LEFT WITH AN UNWORKABLE ELBOW JOINT AND (B)(4) FOR WHICH HE UNDERWENT SUPPLEMENTARY INVASIVE TREATMENT; TREATMENT WAS UNSUCCESSFUL AND THE PATIENT DIED ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN COONRAD/MORREY ELBOW IMPLANT ELBOW PROSTHESIS JDB ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R