BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID GLENOID BASE

    MDR report key: 7185831 · Received January 12, 2018

    Report

    Report Number
    0001825034-2018-00175
    Event Type
    Injury
    Date Received
    January 12, 2018
    Date of Event
    November 22, 2017
    Report Date
    December 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS AND MEDICAL RECORD. VISUAL INSPECTION OF THE RETURNED DEVICE SHOWS THE GLENOID BEARING WAS CUT INTO THREE PIECES DURING EXPLANATION AND CANNOT BE EVALUATED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD AN INITIAL TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY SIX (6) MONTHS POST-IMPLANTATION, OSTEOLYSIS AND A ROTATOR CUFF TEAR, ACCOMPANIED WITH GLENOHUMERAL SUBLUXATION WERE IDENTIFIED. THE ROTATOR CUFF TEAR WAS CONFIRMED TO BE NOT DEVICE RELATED. THE PATIENT UNDERWENT A REVISION PROCEDURE TO A REVERSE SHOULDER ARTHROPLASTY APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION DUE TO THE ROTATOR CUFF TEAR. THE NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT - COMPREHENSIVE SHOULDER SYSTEM MODULAR HEAD, CATALOG#: 113053, LOT#: 160810. HYBRID GLENOID TITANIUM POST, CATALOG#: PT-113950, LOT#: 214500. VERSA-DIAL/COMPREHENSIVE TAPER, CATALOG#: 118001, LOT#: 490520. COMPREHENSIVE NANO HUMERAL, CATALOG#: 115740, LOT#: 247930. (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00174, 00176.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S X-RAYS SHOW GLENOID RADIOLUCENCY OF 1-2 MM IN ZONES 3, 4, AND 6, SIX (6) MONTHS POST-IMPLANTATION. OSTEOLYSIS WAS ALSO IDENTIFIED BUT NO MIGRATION. THERE WAS NO EVIDENCE OF HUMERAL COMPONENT RADIOLUCENCY AND NO HUMERAL COMPONENT OSTEOLYSIS, MIGRATION, OR SUBSIDENCE. SUBLUXATION OF THE GLENOHUMERAL JOINT WAS ALSO IDENTIFIED. NO REVISION HAS BEEN SCHEDULED TO DATE, NO INTERVENTION HAS BEEN REPORTED, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30855 HYBRID GLENOID BASE PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 482390

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R