BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANATOMICAL POLYETHYLENE PEGGED GLENOID, S

    MDR report key: 3840770 · Received May 13, 2014

    Report

    Report Number
    9613350-2014-03520
    Event Type
    Death
    Date Received
    May 13, 2014
    Date of Event
    February 22, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AFFECTED ARE STILL IMPLANTED IN THE PATIENT HENCE THERE WILL BE NO DEVICE INVESTIGATION BE CONDUCED. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, AND THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ZIMMER (B)(4) WILL SUBMIT A FOLLOW UP REPORT ONCE ALL THE DOCUMENTS PERTAINING TO THE DEMISE OF THE PATIENT ARE RECEIVED, SO THAT A MORE DETAILED REPORT CAN BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN A.S. GLENOID S CEMENTED, PEGGED, A HUMERAL ANCHOR UNCEMENTED M AND A SIDUS STEM-FREE SHOULDER HUMERAL HEAD 40-14 ON (B)(6) 2013. IT WAS ALSO REPORTED THAT PRIOR TO SURGERY ON (B)(6) 2013 THE PATIENT HAD ALREADY AN ABLATIO MAMMAE AND DEGENERATION OF THE CERVICAL SPINE, WHICH RESULTED IN A HIGH AMOUNT OF SCAR TISSUE IN THE JOINT REGION AND LEAD TO PINCHING OF THE NERVE. AFTER THE SURGERY, THE PATIENT STARTED TO SUFFER FROM MILD NEUROLOGICAL DEFICIT WITH PARTIAL PLEXUS BRANCHIALIS PARESIS WHICH DETERIORATED WITH TIME. THE PATIENT UNDERWENT NEUROSURGICAL OPERATION OF PLEXUS ON (B)(6) 2013 WITH PLANNED EXPOSURE OF THE PLEXUS AND IF IT WAS GOING TO BE NECESSARY, ALSO WITH NERVE TRANSPLANTATION. INSTEAD, HISTOLOGICAL EVIDENCE OF RECURRENCE OF BREAST CANCER WITH INFILTRATION OF PLEXUS BRACHIALIS WAS FOUND, A MULTILOCAL METASTASIS. THE PATIENT PASSED AWAY ON (B)(6) 2014 WITH THE IMPLANT STILL IN PLACE. PATIENT IS PART OF (B)(4). THE SURGEON DOES NOT CLAIM THAT THE DEATH OF THE PATIENT IS DEVICE RELATED. IN HIS OPINION, THIS SERIOUS ADVERSE EVENT OCCURRED DUE TO THE MEDICAL HISTORY OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285431 ANATOMICAL POLYETHYLENE PEGGED GLENOID, S ANATOMICA GLENOID COMPONENT KWS ZIMMER GMBH NA 2696096

    Patients

    Seq Age Sex Outcome Treatment
    1 Death