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

Model Number	320-01-36
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this 72 y/o female patient had repeatedly dislocated right shoulder.Patient was revised approximately 5 years post op initial reverse total shoulder arthroplasty.The patient was revised to 320-02-38 expanded glenosphere +4 offset and 38mm humeral constrained liner +0.There were no reported issues during the revision procedure.The patient was last known to be in stable condition following the event.Devices will not be returned; hospital policy.No additional information.
Additional Manufacturer Narrative
Device evaluated by mfr: 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 shoulder dislocation and revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.Concomitant medical products: 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (b)(4).320-10-00 - equinoxe reverse tray adapter plate tray +0, (b)(4).320-15-01 - eq rev glenoid plate (b)(4).320-15-05 - eq rev locking screw (b)(4).320-20-00 - eq reverse torque defining screw kit, (b)(4).320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm, (b)(4).320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm, (b)(4).320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, (b)(4), (b)(4).320-36-00 - 36mm humeral liner +0 unconstrained, (b)(4).321-20-00 - equinoxe reverse shoulder drill kit, (b)(4).Tpa-18 - cement restrictor small (b)(4).
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), d8, g4 (remove 501k from initial report-unknown), h4 (remove erroneous date from initial report-unknown), h6: investigation findings.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE PRIMARY SHOULDER COMPONENT
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16016699
• Report Number: 1038671-2022-01614
• Device Sequence Number: 17590820
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K093275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2026

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 Model Number: 320-01-36
• Device Catalogue Number: 320-01-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 11/16/2025; 08/27/2026
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 11/24/2025; 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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 H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female