MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-10-05
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	07/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: - equinoxe reverse 38mm humeral const liner +2.5 (cat# 320-38-13 / serial# (b)(6)).- equinoxe reverse 38mm glenosphere (cat# 320-01-38 / serial# (b)(6)).Product has been received by exactech and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
As reported, approximately 4.5 years post the initial total shoulder arthroplasty, the patient's tray snapped loose from the preserve stem and was loose in the patient's arm.The screw and poly liner remained attached to the tray.The patient was loading a truck when the event occurred.The patient developed soreness and sharp pain, with an inability to lift their arm, and a pain level of 9 out of 10.The patient was revised to a 42mm +4 glenosphere, a +10 humeral tray, and a 42 +2.5 liner.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
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.The reason for the revision is likely due to the disassembly of the torque defining screw and thus the humeral tray and liner assembly from the humeral stem and wear of the humeral liner.Potential contributions may include patient conditions, incomplete seating or forces on the underside of the humeral tray at the time of implantation secondary to unintended contact with protruding bone, or an issue with insufficient application of torque or cross-threading of the screw during assembly.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23309230
• Report Number: 1038671-2025-03122
• Device Sequence Number: 5801611
• Product Code: KWT
• UDI-Device Identifier: 10885862086426
• UDI-Public: 10885862086426
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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 Catalogue Number: 320-10-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male