BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE REVERSE SHOULDER

    MDR report key: 6140182 · Received December 1, 2016

    Report

    Report Number
    0001825034-2016-04982
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    May 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. ROOT CAUSE REMAINS UNDETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR A SHOULDER REVISION PROCEDURE DUE TO UNKNOWN REASONS. THERE HAS BEEN NO REVISION PROCEDURE REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790166 UNKNOWN COMPREHENSIVE REVERSE SHOULDER PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention