BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM BASEPLATE

    MDR report key: 21851656 · Received April 16, 2025

    Report

    Report Number
    0001822565-2025-01024
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    August 28, 2024
    Report Date
    September 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K121543
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 110031178; LOT# 66860970; ITEM# 47430902501; LOT# 65852912; ITEM# 00434901500; LOT# 65901222; ITEM# 01.04223.036; LOT# 3147820; ITEM# 01.04223.030; LOT# 3151019; ITEM# 00430004627; LOT# 63257297; ITEM# 00434901213; LOT# 65990432; ITEM# 00434903700; LOT# 65361565; ITEM# 910-010Z; LOT# GB230102. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) - HEAD. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. 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: B4; B5; D1; D2; D4; D9; G1; G3; G4; G6; H1; H2; H4; 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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: G4; H2; H3; H6. CORRECTED: B5; D1; D2; D4; H4 . D6 SHOULD REMOVE IMPLANT/EXPLANT DATES AS DEVICE WAS NOT IMPLANTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D1; D2; D4; G1; G3; G4; G6; H1; H2; H4; H6. H6: PROPOSED COMPONENT CODE - MECHANICAL (G04) HEAD. 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 SHOULDER REVISION APPROXIMATELY ONE (1) YEAR AND ONE (1) MONTH POST-IMPLANTATION DUE TO A FRACTURED GLENOID BONE. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION OF A REVERSE SHOULDER APPROXIMATELY 3 YEARS AGO. DURING THE INITIAL IMPLANTATION, THE GLENOID BONE FRACTURED SO THE PATIENT WAS CONVERTED TO A HEMI INSTEAD. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY APPROXIMATELY 1 YEAR AGO DUE TO THE FRACTURED GLENOID BONE. 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
    116042 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM BASEPLATE PROSTHESIS, SHOULDER, NON-CONSTRAINED KWT ZIMMER BIOMET, INC. NI 65901222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE NARRATIVE IN H11.