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

Model Number	EQUINOXE REVERSE 38MM GLENOSPHERE
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: equinoxe reverse shoulder glenosphere locking screw (cat# 320-15-05 / serial# (b)(6).Equinoxe reverse shoulder fixed angle torque defining screw kit (cat# 302-20-00 / serial# (b)(6).Equinoxe reverse shoulder humeral adapter tray +0 (cat# 320-10-00 / serial# (b)(6).Equinoxe reverse shoulder humeral liner 38mm +2.5mm (cat# 320-38-03 / serial# (b)(6).Equinoxe, humeral stem primary, press fit 7mm (cat# 300-01-07 / serial# (b)(6).Rs glenoid plate post aug, 8 deg, left (cat# 320-15-03 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately fourteen days post initial left tsa, the 65 y/o male patient reverse shoulder was revised due to infection.All components were revised due to an infection.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The devices are not available for evaluation due to hospital disposed the implants.
Additional Manufacturer Narrative
The glenosphere, liner and adapter tray were appropriately released for distribution.The reason for the patient's infection and subsequent revision procedure as related to the devices cannot be conclusively determined.There was no medical or clinical information provided.These devices are used for treatment not diagnosis.

• Brand Name: EQUINOXE REVERSE SHOULDER COMPONENTS
• 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: miguel soza
• MDR Report Key: 18735595
• Report Number: 1038671-2024-00257
• Device Sequence Number: 14888270
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K06356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2026

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: EQUINOXE REVERSE 38MM GLENOSPHERE
• Device Catalogue Number: 320-01-38
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 06/16/2026
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 05/24/2024; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2023
• 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: 65 YR
• Patient Sex: Male