MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 8MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	300-30-08
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, the patient had an initial right tsa on (b)(6) 2021.The patient presented on 26-oct-2023 with deep infection.The case report form indicates that this event is definitely not related to device and definitely related to procedure.Outcome was resolved on 26-oct-2023 with medical intervention - completion of 1 year of abx with no recurrent infection.
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): s289628 320-42-00 - 145-deg pe 42mm hum liner +0.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6 mdr section codes updated/corrected: b, c, d, e, g the reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE PRESERVE STEM 8MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18196997
• Report Number: 1038671-2023-02847
• Device Sequence Number: 6403430
• Product Code: PHX
• UDI-Device Identifier: 10885862515766
• UDI-Public: 10885862515766
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 300-30-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White