MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER SYSTEM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 2.5 years post initial tsa, the 82 y/o obese male patient experienced deep infection.Patient had anterior shoulder pain without injury for 6 months.The event is still ongoing.No additional information.
Additional Manufacturer Narrative
Concomitant products: equinoxe preserve stem 10mm (cat# 300-30-10), equinoxe reverse 42mm glenosphere (cat# 320-01-42), equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00), equinoxe reverse 42mm humeral liner +0 (cat# 320-42-00).As reported by the equinoxe shoulder study, approximately 2.5 years post initial tsa, the 82 y/o obese male patient experienced deep infection.Patient had anterior shoulder pain without injury for 6 months.The event is still ongoing, the medical action was to observe the situation.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of pain and infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness [obesity and multiple joint maladies], unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b3 (unknown date in february of 2022), d1, d4(remove all from the initial report-suspect device unknown) d3, e4 (remove entry for initial report), h6: health effect clinical code, health effect- impact code, component code, type of investigation and investigation conclusion.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE SHOULDER SYSTEM
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16018610
• Report Number: 1038671-2022-01615
• Device Sequence Number: 5692961
• Product Code: KWT
• UDI-Device Identifier: 10885862186690
• UDI-Public: 10885862186690
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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 Model Number: RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT
• Device Catalogue Number: 320-15-04
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White