BEUDAMED
    FDA Adverse Event Injury Summary report: N

    40MM POLY LINER PLUS 6MM OFS

    MDR report key: 13368762 · Received January 27, 2022

    Report

    Report Number
    0001822565-2022-00233
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    January 17, 2022
    Report Date
    April 6, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    UDI-DI
    00889024269156
    PMA / PMN Number
    K052906
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT: 00434901213, LOT: 63700625, TM,REVERSE STEM 12MM X 130MM. CAT: 00434901500, LOT: 63715593, 15MM POST LENGTH BASE PLATE. CAT: 00434904011, LOT: 63653808,TM REVERSE 40MM GLENOSPHERE. CAT: 01.04223.036, LOT: 2921546, NVERS/REVERS SCR SYST 4.5- 36. CAT: 01.04223.036, LOT: 2921529, INVERS/REVERS SCR SYST 4.5- 36. REPORT SOURCE: FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2022 - 00234.

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED SIGNS OF WEAR. ALL FEATURES OF THE BACKSIDE SHOW DAMAGE. GOUGES ARE SEEN IN THE SPHERICAL RADIUS. REVIEW OF THE AVAILABLE RADIOGRAPHS IDENTIFIED THAT LEFT TOTAL SHOULDER REVERSED ARTHROPLASTY WITH POSSIBLE LOOSENING OF THE GLENOID COMPONENT WITH THE ASSOCIATED CHANGING ORIENTATION OF THE GLENOSPHERE AS WELL AS POLYETHYLENE WEAR OF THE GLENOHUMERAL COMPONENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY FOUR YEARS POST INITIAL DUE TO DISASSOCIATION OF POLY LINER FROM THE STEM. THE LOOSE LINER WAS EXPLANTED AND A NEW POLY LINER WAS IMPLANTED. NO OTHER IMPLANTS WERE REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85615 40MM POLY LINER PLUS 6MM OFS PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. 00-4349-040-06 62977613 00889024269156

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention| H