BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 13634059 · Received March 1, 2022

    Report

    Report Number
    0001825034-2022-00424
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    March 24, 2021
    Report Date
    June 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304543201
    PMA / PMN Number
    K193373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT IS GETTING PATHOLOGY TESTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MIR 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. DEVICE PRODUCT CODE : PHX. CONCOMITANT PRODUCTS: PART# XL-115363; LOT# 798550. PART# PT-113950; LOT# 682270. PART# 113648; LOT# 647510. PART# 118001; LOT# 384530. PART# 115310; LOT# 042090. PART# 180560; LOT# 114970. PART# 180558; LOT# 330140. PART# 180553; LOT# 687720. PART# 180553; LOT# 093880. PART# 115398; LOT# 714870. PART# 115330; LOT# 157840. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 00425, 0001825034 - 2022 - 00426, 0001825034 - 2022 - 00427, 0001825034 - 2022 - 00428, 0001825034 - 2022 - 00429, 0001825034 - 2022 - 00430, 0001825034 - 2022 - 00431, 0001825034 - 2022 - 00432, 0001825034 - 2022 - 00433, 0001825034 - 2022 - 00434, 0001825034 - 2022 - 00435.

    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 UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. METALLOSIS CAUSED BETWEEN THE ARTICULATION OF THE TRAY AND GLENOSPHERE IS A SECONDARY FAILURE OF THE POLY WEAR. LOOSENING IS ALSO A SECONDARY FAILURE OF POLY WEAR. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. 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

    THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVERSE SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, IN AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING WITH PERIPROSTHETIC OSTEOLYSIS, WEAR OF THE POLY COMPONENT, AND METALLOSIS. 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
    1304751 COMP RVS TRAY CO 44MM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 944340 00880304543201

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention| H SEE H10 NARRATIVE.