BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TM REVERSE SHOULDER RETENTIVE POLY LINER

    MDR report key: 6504338 · Received April 19, 2017

    Report

    Report Number
    0001822565-2017-02364
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    March 22, 2017
    Report Date
    June 6, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK121543
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER: (B)(4). THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED THROUGH REVIEW OF THE DEVICE HISTORY RECORDS AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE WAS RETURNED FOR EVALUATION AND DIMENSIONS TAKEN ARE WITHIN SPECIFICATION. THE ITEM EXHIBITS MULTIPLE HEAVY GOUGES. A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE IDENTIFIED. A REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO ACTIONS ARE REQUIRED AT THIS TIME. THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. CONCOMITANT DEVICES - 40MM DIAMETER GLENOSPHERE CATALOG #: 00434904011 LOT #: 63481217, NON-POROUS HUMERAL STEM CATALOG #: 00435001613 LOT #: 62684241, 15MM BASEPLATE CATALOG #: 00434901500 LOT #: 63573746, INVERSE/REVERSE SCREW SYSTEM CATALOG #: 01.04223.036 LOT #: 2852837, INVERSE/REVERSE SCREW SYSTEM CATALOG #: 01.04223.036 LOT #: 2860432, TRABECULAR METAL REVERSE DRILL CATALOG #: 47430904601 LOT #: 63560370, TRABECULAR METAL REVERSE 2.5MM PIN CATALOG #: 47430902501 LOT #: 63581735, TRABECULAR METAL GLENOID CANNULATED DRILL CATLAOG #: 47430706100 LOT #: 63555928. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER ARTHROPLASTY REVISION 16 DAYS AFTER IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, IT WAS FOUND THAT THE LINER HAD DISASSOCIATED FROM THE HUMERAL STEM. NO FURTHER ADVERSE EVENT IS REPORTED, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SHOULDER ARTHROPLASTY REVISION 16 DAYS AFTER IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, IT WAS FOUND THAT THE LINER HAD DISASSOCIATED FROM THE HUMERAL STEM. A NEW POLY LINER WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO FURTHER ADVERSE EVENT IS REPORTED, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286460 ZIMMER TM REVERSE SHOULDER RETENTIVE POLY LINER PROSTHESIS, SHOULDER KWT ZIMMER, INC. N/A 61532202

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R