BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVERSE/REVERSE SCREW SYSTEM, 4.5-30

    MDR report key: 5409411 · Received February 4, 2016

    Report

    Report Number
    9613350-2016-00135
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    November 10, 2015
    Report Date
    June 17, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER FDA¿S DIRECTIVE, MEDWATCH REPORT HAS BEEN RESUBMITTED FOR REMOVING THREE ZEROS IN THE PREFIX OF MFR NUMBER(0009613350-2016-00135-2). ALL THE INFORMATION CAPTURED AS PER 0009613350-2016-00135-2 INCLUDING G4(DATE RECEIVED BY MANUFACTURER) EXCEPT B4. IT WAS REPORTED THAT A TSA WAS IMPLANTED ON (B)(6), 2015 AND A PARTIAL REVISION WAS PERFORMED ON THE (B)(6), 2015 DUE TO BENT LINER (SEE (B)(4)- MFR 1822565-2015-02698). THE SCREWS WERE NOT REVISED. NO TREND IDENTIFIED. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. X-RAYS DATED (B)(6) 2015: AP- VIEW OF THE LEFT SHOULDER. NO SIGNS OF LOOSENING AROUND THE SCREWS. THE SCREWS SEEMED TO BE WELL IMPLANTED. X-RAYS DATED (B)(6) 2015: SIMILAR TO THE PICTURE TAKEN ON OCTOBER, AGAIN AN AP- VIEW OF THE LEFT SHOULDER. NO SIGNS OF LOOSENING AROUND THE SCREWS. THE SCREWS SEEMED TO BE WELL IMPLANTED. THE PRODUCT WAS NOT RECEIVED FOR INVESTIGATION BECAUSE STILL IMPLANTED. REVIEW OF THE X-RAYS DID NOT REVEAL ANY ISSUE RELATED TO THE INVERSE/REVERSE SCREWS SYSTEM. THE REPORTED EVENT STATED THAT THE LINER WAS FOUND TO BE BENT AND THIS EVENT IS NOT RELATED TO THE SCREWS. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTED IN THE DFMEA WHICH IS AVAILABLE FOR EVERY ZIMMER IMPLANT AND IS CONTINUOUSLY MONITORED AND UPDATED. THE PRODUCT WAS NOT INVOLVED IN THE EVENT. NO FAILURE DETECTED AND THEREFORE NO ROOT CAUSE FOUND. THE NEED FOR CORRECTIVE ACTIONS IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION DUE TO BENT LINER.

    Additional Manufacturer Narrative · 1

    ADDITONAL INFORMATION WAS RECEIVED ON FEBRUARY 9, 2016. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES FOR REVIEW. X-RAY PICTURES WERE RECEIVED AND WILL BE REVIEWED WITHIN THE INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICE, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THIS IS A SPLIT CASE WITH ZIMMER INC (B)(4) REFERENCE NUMBER (B)(4) (MFR 1822565-2015-02698, TM LINER).

    Description of Event or Problem · 1

    IT BECAME AWARE ON (B)(6) 2016 THAT THE SCREWS REMAIN IN THE PATIENT BECAUSE WERE NOT AFFECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED AN INVERSE/REVERSE SCREW SYSTEM, 4.5-30 ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT HIT THE DOOR AND HAD TO BE REVISED ON (B)(6) 2015. IT WAS OBSERVED THAT THE GLENOSPHERE WAS NOT IN PLACE AND THE POLYETHYLENE LINER WAS DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69535 INVERSE/REVERSE SCREW SYSTEM, 4.5-30 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM KWT ZIMMER GMBH NA 2794523

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R