MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE PRESERVE STEM 7MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	300-30-07
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 320-08-46 - glenosphere exp 46mm +4mm offset (b)(6), 320-10-15 - humeral tray +15mm (b)(6), 320-15-05 - eq rev locking screw (b)(6), 320-20-00 - eq reverse torque defining screw kit (b)(6), 320-46-13 - 145-deg pe 46mm const hum liner +2.5 (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent a reverse total shoulder revision arthroplasty.Subsequently, the patient's humeral stem and torque defining screw disassembled which resulted in disassembly of the humeral tray and humeral stem.As a result, the patient underwent a right shoulder revision approximately 2 year and 6 months after initial implantation of the stem and 6 months after the first revision.No further patient impact reported.No further information available.This is report 2 of 2 for this event.

• Brand Name: EQUINOXE PRESERVE STEM 7MM
• 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: 23819735
• Report Number: 1038671-2025-03565
• Device Sequence Number: 9386819
• Product Code: KWS
• UDI-Device Identifier: 10885862515759
• UDI-Public: 10885862515759
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/16/2025

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: 300-30-07
• 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: 11/25/2025
• Initial Report FDA Received Date: 12/16/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Male