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

Catalog Number	320-20-00
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 319-01-32 - steinmann pin sterile 3.2mm x 178mm (b)(6).320-10-05 - equinoxe reverse tray adapter plate tray +5 (b)(6).320-15-05 - eq rev locking screw (b)(6).320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm (b)(6) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm (b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm (b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm (b)(6) 320-31-36 - glenosphere, 36mm (b)(6) 320-31-40 - glenosphere, 40mm (b)(6) 320-35-04 - small posterior augment glenoid plate, right (b)(6) 320-40-03 - 145-deg pe 40mm hum liner +2.5 (b)(6) 321-52-07 - 3.2mm drill bit sterile (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 patient who had a right rtsa, underwent a revision procedure.The humeral tray was dissociated from the preserve stem.The torque screw was explanted and intact (did not appear broken).The reported event was related to a device breakage but no parts or pieces were in the wound site.The torques screw was revised.There were no surgical delays reported.The patient was last known to be in stable condition following the event.No x-rays were available.The explanted device is available for return.No further information.This is 1 of 2 reports for this event.

• 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, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25089265
• Report Number: 1038671-2026-00538
• Device Sequence Number: 20091452
• Product Code: KWT
• UDI-Device Identifier: 10885862086518
• UDI-Public: 10885862086518
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• 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): 05/05/2026

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: 320-20-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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 Age: 60 YR
• Patient Sex: Male