MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE SHOULDER SYSTEM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-01-38
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3 months post op initial left tsa, this 50 y/o female patient was revised due to dislocation.Reverse components were removed and surgeon put a hemi in.Patient was last known to be in stable condition following the event.Device not returning - disposed at hospital.No delay/prolongation.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.(d10) concomitant device(s): 320-20-22, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 22mm.320-20-22, (b)(6)- eq rev compress screw lck cap kit, 4.5 x 22mm.320-20-26, (b)(6) - eq rev compress screw lck cap kit, 4.5 x 26mm.320-15-01, (b)(6) - eq rev glenoid plate.320-15-05, (b)(6) - eq rev locking screw.300-01-07, (b)(6) - equinoxe, humeral stem primary, press fit 7mm.320-20-00, (b)(6) - eq reverse torque defining screw kit.320-20-22, (b)(6) - eq rev compress screw lck cap kit, 4.5 x 22mm.320-38-00, (b)(6) - equinoxe reverse 38mm humeral liner +0.320-10-00, (b)(6) - equinoxe reverse tray adapter plate tray +0.
Additional Manufacturer Narrative
Section h10: (h3) upon review of the available information, there is no evidence that this is a device related malfunction and there is no allegation against the device.Implantation of a total joint could result scapular notching and dislocation.The most likely cause of the reported event is patient conditions.
Additional Manufacturer Narrative
H6: corrected type of investigation, investigation findings, and investigation conclusions.Manufacturer narrative updated: based on review of all available information, there is no evidence to suggest that the reported event is related to any product problems or use issues.The cause of the dislocation cannot be conclusively determined; however, the reported dislocation may have been related to several potential factors including but not limited to the implant selection, the surgical procedure itself, patient anatomical issues, patient activity after surgery and/or underlying patient medical conditions.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d4 (remove all from initial report-suspect device unknown), g2 (correct initial report -australia), g4 (remove from initial report-unknown) g3 (correct initial report to 23-aug-2023), h4 (remove date from initial report) h6: types of investigation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE REVERSE SHOULDER SYSTEM
• 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17756950
• Report Number: 1038671-2023-02280
• Device Sequence Number: 17834684
• Product Code: KWT
• UDI-Device Identifier: 10885862086389
• UDI-Public: 10885862086389
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/31/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 320-01-38
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 09/27/2024; 12/12/2025
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 01/12/2024; 09/27/2024; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female