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

Catalog Number	320-01-42
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): (b)(6) 300-01-15 - equinoxe, humeral stem primary, press fit 15mm.(b)(6) 320-10-10 - equinoxe reverse tray adapter plate tray +10.(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) 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm.(b)(6) 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm.(b)(6) 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm.(b)(6) 320-42-00 - equinoxe reverse 42mm humeral liner +0.(b)(6) 321-52-07 - 3.2mm drill bit sterile.(b)(6) 321-52-09 - 3.2mm k-wire, trocar tip.
Event or Problem Description
As reported, 3 days post op initial right tsa, this 49 y/o male patient was revised due to dislocation.Surgeon decided to change the liner and glenosphere to create a tighter construct.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Unable to obtain photos/x-rays.Product not returning - disposed by hospital.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the liner dissociation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, d1, d8, g3 (correct date on initial report to 14-apr-2023), h4 (remove erroneous date from initial report), h6: investigation findings and investigation conclusion.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 ; 2320 nw 66th ct; gainesville, FL ; 3523771140
• MDR Report Key: 16941087
• Report Number: 1038671-2023-01003
• Device Sequence Number: 7562547
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• 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
• 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,Followup
• Report Date (Section B): 12/08/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-01-42
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 12/03/2025
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 10/05/2023; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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.
• Patient Age: 49 YR
• Patient Sex: Male