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	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 4 years post op initial left tka, this 88 y/o female patient was revised due to dislocation.Glenosphere and liner were exchanged to expanded 38mm glenosphere and +2.5 constrained liner.Patient was last known to be in stable condition following the event.Device is not returning - disposed at the hospital.
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation (d10) concomitant device(s): eq rev glenoid plate, 320-15-01 ,6234160.Eq rev compress screw lck cap kit, 4.5 x 30mm, 320-20-30, 6241389.Eq rev locking screw 320-15-05 6217896 eq rev compress screw lck cap kit, 4.5 x 34mm, 320-20-34 6239591.Equinoxe, humeral long stem 8mm 175mm ,306-01-08 ,3786648.Equinoxe reverse tray adapter plate tray +0, 320-10-00 ,6257804.Eq reverse torque defining screw kit, 320-20-00, 6237635.Equinoxe reverse 38mm humeral liner +0, 320-38-00, 6218754.
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 dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament re-construction.
Additional Manufacturer Narrative
Section h10: (g2) report source - company representative should have been checked (g4) date received by manufacturer ¿ date on final submission should have been (16-dec-2023 (g6) type of report - 30-day should have been checked along with follow-up.
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 devices unknown) g4 (remove 501k from initial report-unknown) h6: types, findings and investigation conclusions.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: 17640866
• Report Number: 1038671-2023-02069
• Device Sequence Number: 14861074
• 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: 2019
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/06/2026

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: 08/07/2023
• Supplement Date Received by Manufacturer: 08/07/2023; 01/12/2024; 12/26/2025
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 01/10/2024; 01/12/2024; 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female