MAUDE Adverse Event Report: EXACTECH, INC. 145-DEG PE 42MM CONST HUM LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 42MM GLENOSPHERE
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately six months post initial right tsa, the 66 y/o male patient was revised due to pain in his shoulder.Prior to surgery, patient had a +5 tray, +0mm constrained liner and 42mm glenosphere.Patient glenosphere was exchanged for a 38mm lateralized glenosphere and a +5mm tray with a +0mm constrained liner.There was no breakage of the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Images received.The device is not available for evaluation as hospital doesn't release implants.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, d1, d4, d10, g3, g4, g6, h2 and h4 have been updated accordingly.Section b5, d10: additional information received indicates that here are all the parts that were removed during the case.- eq rev locking screw (cat# 320-15-05 / serial# (b)(6).- equinoxe reverse 42mm humeral liner +0 (cat# 320-42-00 / serial# (b)(6).- equinoxe reverse tray adapter plate tray +0 (cat# 320-10-00 / serial# (b)(6).- eq reverse torque defining screw kit (cat# 320-20-00 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, h4, h6 mdr section codes updated/corrected: a, b, c, d, g the revision reported was likely the result of pain as reported.A secondary finding was prosthesis wear noted on the humeral liner, which is likely the result of impingement with the scapula.However, this cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 145-DEG PE 42MM CONST HUM 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16786602
• Report Number: 1038671-2023-00794
• Device Sequence Number: 5678996
• Product Code: KWT
• UDI-Device Identifier: 10885862086716
• UDI-Public: 10885862086716
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2025

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: 01/09/2024
• Device Model Number: EQUINOXE REVERSE 42MM GLENOSPHERE
• Device Catalogue Number: 320-42-10
• 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: 04/01/2023
• Supplement Date Received by Manufacturer: 04/30/2023; 09/16/2025
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 06/06/2023; 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2019
• 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: 66 YR
• Patient Sex: Male