MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant product: eq rev torque screw kit (cat# 320-20-00 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 2.5 years post initial left tsa, the 67 y/o male patient had a revision due to poly disassociated.The patient was revised to upsized humeral tray and liner.The patient is stable.There was no breakage the device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain images/x-rays.The devices are not available for evaluation due to hospital policy.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported was likely the result of disassembly between the humeral liner and humeral tray.However, this cannot be confirmed and potential contributions from patient conditions, an unreported traumatic event, incomplete seating of the humeral liner during implantation, forceful contact between the liner and glenoid bone (scapular notching), or a combination of the above to the reported disassembly of the humeral liner cannot be determined as the devices were not returned for evaluation and images/radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE 38MM HUMERAL CONST 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
• MDR Report Key: 18946700
• Report Number: 1038671-2024-00601
• Device Sequence Number: 20595722
• Product Code: KWT
• UDI-Device Identifier: 10885862086679
• UDI-Public: 10885862086679
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 10/08/2025

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 Expiration Date: 07/12/2023
• Device Model Number: EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0
• Device Catalogue Number: 320-38-10
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2018
• 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: 67 YR
• Patient Sex: Male