MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 9MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-30-09
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Insufficient Information (4580)
Date of Event	12/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: d10: 322-10-05 - humeral adapter tray, +5: (b)(6).322-46-03 - 145-deg pe 46mm hum liner +2.5: (b)(6).320-08-46 - glenosphere exp 46mm +4mm offset: (b)(6).320-15-05 - eq rev locking screw: (b)(6).320-15-01 - eq rev glenoid plate: (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).320-20-26 -eq rev compress screw lck cap kit, 4.5 x 26mm: (b)(6).320-20-30 -eq rev compress screw lck cap kit, 4.5 x 30mm: (b)(6).320-20-00 - eq reverse torque defining screw kit: (b)(6).Customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent a right reverse total shoulder revision.Subsequently, the patient's torque defining screw separated from the humeral stem resulting in disassociation of the humeral tray.As a result, the patient underwent an additional shoulder revision surgery approximately 6 months after their first revision surgery and 6 years after their initial implantation.No further patient impact reported.No further information available.This is report 2 of 2 for this event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6 - health effect - clinical code and medical device problem code.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE PRESERVE STEM 9MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23981470
• Report Number: 1038671-2026-00017
• Device Sequence Number: 10609010
• Product Code: KWS
• UDI-Device Identifier: 10885862515773
• UDI-Public: 10885862515773
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 02/10/2026

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: 300-30-09
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2018
• 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; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male