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

Catalog Number	320-15-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Aseptic loosening (4883)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a clinical study, that a 67 yo male patient, who had a rtsa, underwent a revision procedure due to aseptic glenoid loosening.A loose glenoid baseplate, pain then broken screw and functional loss necessitated the revision.The torque screw, humeral tray, humeral liner, glenosphere, glenosphere locking screw, glenoid base plate, and compression screw / locking cap were revised.The study indicated it was possibly related to the devices and the procedure.The outcome stated resolved.No further information.This is 1 of 2 reports for this event.This is 1 of 2 events for this patient.
Additional Manufacturer Narrative
D10: 300-30-06 - eq preserve stem 6mm: (b)(6).320-46-00 - eq reverse 46mm humeral liner +0: (b)(6) 320-10-00 - eq reverse tray adapter plate tray +0: (b)(6) 320-15-05 - eq rev locking screw: (b)(6) 320-01-46 - equinoxe reverse 46mm glenosphere: (b)(6) should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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: 24624294
• Report Number: 1038671-2026-00290
• Device Sequence Number: 12910636
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-15-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White