MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: equinoxe reverse 42mm humeral liner +2.5 (cat# 320-42-03 / serial# (b)(4).Eq rev locking screw (cat# 320-15-05 / serial# (b)(4).Rs expanded glenosphere 42mm, +4mm offset (cat# 320-02-42 / serial #: (b)(4).Eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(4).As reported by the equinoxe shoulder study, the 69 y/o male patient experienced humeral fracture.Patient had meta/diaphyseal fracture removing well fixed stem due to tray failure.The event is still ongoing.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the shoulder fracture occurred during removal of a well- fixed device due to tray failure.These devices are used for treatment not diagnosis.
Event or Problem Description
As reported by the equinoxe shoulder study, the 69 y/o male patient experienced humeral fracture.Patient had meta/diaphyseal fracture removing well fixed stem due to tray failure.The event is still ongoing.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: a2, d1, d2a, d4 catalogue #, udi, d4 (remove expiration date, remove serial number (unknown), g4, h4 (remove manufactured date (unknown), h6 health effect impact code, medical device problem code, component code, h6 type of investigation, investigation conclusion.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1/d2a/d2b, d4, d6b, h4, h6.Mdr section codes updated/corrected: a, b.Serial number, expiration and manufactured dates unknown.The reason for the adverse event reported was likely due to a periprosthetic bone fracture as reported.The cause of the bone fracture cannot be conclusively determined but may be related to a patient condition or high forces during extraction of the well-fixed stem.However, this cannot be confirmed because the devices were not returned for evaluation, and relevant patient information, images, or radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM
• 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 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16142506
• Report Number: 1038671-2023-00035
• Device Sequence Number: 15105876
• Product Code: KWS
• UDI-Device Identifier: 10885862079336
• UDI-Public: 10885862079336
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• Device Catalogue Number: 300-01-15
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 07/07/2025; 10/02/2025
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 07/07/2025; 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White