MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-10-00
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial right tsa.The patient's shoulder was dislocating on and off; no fall or any trauma was done to the shoulder.The patient was revised.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Concomitants: (b)(6), 300-01-10 - equinoxe humeral stem primary press fit 10mm, (b)(6), 320-01-38 - equinoxe reverse 38mm glenosphere, (b)(6), 320-15-01 - eq rev glenoid plate, (b)(6), 320-15-05 - eq rev locking screw, (b)(6), 320-20-00 - eq reverse torque defining screw kit, (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6), 320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm, (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(6), 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.The revision reported was likely due to reported dislocation, prosthesis wear, and unintended articulation between metal components resulting in metal debris.The sequence of event regarding the dislocation and component wear cannot be determined.It is possible that the shoulder dislocated, leading to abnormal contact between the components resulting in wear of the humeral liner and tray.Alternatively, there may have been high uneven loading of the glenosphere on the humeral liner which led to wear of the humeral liner and eventual dislocation and humeral tray wear.However, this cannot be confirmed based on the provided information.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 23556180
• Report Number: 1038671-2025-03334
• Device Sequence Number: 21363033
• Product Code: KWT
• UDI-Device Identifier: 10885862086419
• UDI-Public: 10885862086419
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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 Catalogue Number: 320-10-00
• 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: 11/12/2025
• Initial Report FDA Received Date: 11/14/2025
• Date Device Manufactured: 11/02/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female