BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD RGX AUG - SM

    MDR report key: 14565049 · Received June 1, 2022

    Report

    Report Number
    0001825034-2022-01324
    Event Type
    Injury
    Date Received
    June 1, 2022
    Date of Event
    September 28, 2017
    Report Date
    July 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K111746
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ITEM# 3735118N; LOT# 1474530D2, ITEM# 3735118N; LOT# 18/221244, ITEM# 3735118N; LOT# 18/221244, ITEM# 3735118N; LOT# 18/221244, ITEM# 3735118N; LOT# 18/221244, ITEM# 3735120N; LOT# 18/154881, REPORT SOURCE: FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: A4; B4; B5; G3; G6; H1; H2; H6 IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE DEVICE IS NOT SUPPLIED BY ZIMMER BIOMET IN WHICH ZIMMER BIOMET DOES NOT HOLD REPORTING RESPONSIBILITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED IMPLANT FRACTURE APPROXIMATELY TWO (2) MONTHS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460812 COMPR SRS MOD RGX AUG - SM PROSTHESIS, SHOULDER, NON-CONSTRAINED KWT ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other