MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MINI HUMERAL TRAY +5 MM THICKNESS +3 MM TAPER OFFSET 40 MM DIAMETER; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	110031403
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Common device name: phx.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.Zimmer biomet will continue to monitor for trends.Associated products and reports: 0001822565-2023-00620, item#110031421; lot#65369976.Other associated products: item# 010000589; lot#378380.Item#110030777; lot#64515982.Item#110031403; lot#65706928.Item#110031422; lot#64489381.
Event or Problem Description
It was reported patient underwent right shoulder revision due to instability.During the procedure, the humeral bearing was disassociated with the humeral tray.The bearing, humeral tray and glenosphere were removed and replaced.No pieces were retained by the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.Associated products and reports: 0001822565-2023-00620-1, item#110031421; lot#65369976.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: MINI HUMERAL TRAY +5 MM THICKNESS +3 MM TAPER OFFSET 40 MM DIAMETER
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16517305
• Report Number: 0001822565-2023-00619
• Device Sequence Number: 3290792
• Product Code: PHX
• UDI-Device Identifier: 00887868231353
• UDI-Public: (01)00887868231353(17)301027(10)64909220
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K181611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 110031403
• Device Lot Number: 64909220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male