MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-55-01
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Aseptic loosening (4883)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 300-01-13 - equinoxe, humeral stem primary, press fit 13mm: unk.322-40-00 - 145-deg pe 40mm hum liner +0: unk.322-10-00 - humeral adapter tray, +0: unk.320-31-40 - glenosphere, 40mm: unk.320-55-35 - central screw baseplate central screw, 35mm: (b)(6).320-55-98 - central screw baseplate one-lock plate/cap kit: (b)(6).320-55-99 - csb glenosphere screw: (b)(6).321-52-11 - csb 3.2mm drill: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported via a clinical study, that a 62 yo male patient, who had a stemless tsa, was reported to have aseptic glenoid loosening.Revision occurred.The standard reverse humeral tray, humeral liner, glenosphere, glenosphere locking screw, and glenoid baseplate were removed.Allograft was impacted into the glenoid defect.No intra-operative complications occurred.The study indicated the event was definitely related to the devices and possible related to the procedure.Outcome indicates resolved.No further information.

• Brand Name: EQUINOXE
• 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 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24754214
• Report Number: 1038671-2026-00363
• Device Sequence Number: 8772480
• Product Code: PHX
• UDI-Device Identifier: 10885862625618
• UDI-Public: 10885862625618
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K233482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 320-55-01
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White