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

Catalog Number	320-01-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 304-22-09 - 8.5mm platform fx stem right: (b)(6), 320-10-00 - eq rev tray adapter plate tray +0: (b)(6), 320-15-01 - eq rev glenoid plate: (b)(6), 320-15-05 - eq rev locking screw: (b)(6), 320-20-00 - eq revtorque defining screw kit: (b)(6), 320-38-03 - eq rev 38mm humeral liner +2.5: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a female patient, who had a right rtsa, underwent a revision procedure.The patient was sent for pathology assessment on the shoulder.The results came back positive with infection.Intraop findings showed pus on the glenoid prosthesis.All implants were removed and a cement spacer was put in.There was no device breakage or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted devices are not available for return as they were discarded by the customer.No images were available.No further information.

• Brand Name: EQUINOXE
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24811484
• Report Number: 1038671-2026-00396
• Device Sequence Number: 20340249
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 07/09/2026

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 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: 03/22/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female