BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM REVERSE STEM 12MM X 130MM

    MDR report key: 13368745 · Received January 27, 2022

    Report

    Report Number
    0001822565-2022-00234
    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
    00889024268951
    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

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT: 00434904006, LOT: 62977613, 40MM POLY LINER PLUS 6MM OFS; CAT: 00434901500, LOT: 63715593, 15MM POST LENGTH BASE PLATE; CAT: 00434904011, LOT: 63653808, TM REVERSE 40MM GLENOSPHERE; CAT: 01.04223.036, LOT: 2921546, INVERS/REVERS SCR SYST 4.5- 36; CAT: 01.04223.036, LOT: 2921529, INVERS/REVERS SCR SYST 4.5- 36. FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. 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: 0001822565-2022-00233.

    Description of Event or Problem · 0

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

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84564 TM REVERSE STEM 12MM X 130MM PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. 00-4349-012-13 63700625 00889024268951

    Patients

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