MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 46MM HUMERAL LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 46MM GLENOSPHERE
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant devices: equinoxe preserve stem 10mm (cat# 320-30-10 / serial# (b)(6)) glnd kwire (cat# 315-35-00 / serial# (b)(6)) equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6)) eq rev glenoid plate (cat# 320-15-01 / serial# (b)(6)) eq rev locking screw (cat# 320-15-05 / serial# (b)(6)) eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6)) eq rev compress screw lck cap kit, 4.5 x 18mm (cat# 320-20-18 / serial# (b)(6)) eq rev compress screw lck cap kit, 4.5 x 22mm (cat# 320-20-22 / serial# (b)(6) ) eq rev compress screw lck cap kit, 4.5 x 22mm (cat# 320-20-22 / serial# (b)(6) ) equinoxe reverse 46mm humeral liner +0 (cat# 320-46-00 / serial# (b)(6) ) equinoxe reverse shoulder drill kit (cat# 321-20-00 / serial# (b)(6)) additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that an 80 yo male patient, initial shoulder implanted on (b)(6) 2017, underwent a revision procedure on (b)(6) 2024, approximately 6 years 10 months post the initial procedure.The patient was revised due to issues since their primary surgery, could be infection, but the surgeon wants to make a report just in case.The surgeon suspects possible poly wear.There were no device breakages or surgical delays during the procedure.No x-rays were provided.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis as they were sent to pathology at the hospital.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, h4, h6.Mdr section codes updated/corrected: a, b, c, d, g.The revision reported may have been the result of suspected infection as reported.The suspected prosthesis wear and infection could not be confirmed on the images provided.Additionally, potential contributions of user or patient-related considerations to the event could not be assessed as radiographs or relevant clinical information 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 REVERSE 46MM HUMERAL LINER +0
• 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 court; gainesville FL 32653
• Manufacturer Contact: matt collins
• MDR Report Key: 19121871
• Report Number: 1038671-2024-00866
• Device Sequence Number: 12819576
• Product Code: KWT
• UDI-Device Identifier: 10885862086730
• UDI-Public: 10885862086730
• Combination Product (Y/N): N
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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 Expiration Date: 10/02/2022
• Device Model Number: EQUINOXE REVERSE 46MM GLENOSPHERE
• Device Catalogue Number: 320-46-00
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2017
• 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 Sex: Male