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

Catalog Number	320-38-03
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, who had an initial right shoulder implanted on an unknown date, underwent a revision procedure in (b)(6) 2025.This was a humeral liner exchange as the patient kept dislocating post-op.The surgeon removed the liner, inserted a constrained liner, reduced and closed the wound.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted device is not available for return as it was disposed of by the customer.Device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm; (b)(6), 320-10-00 - equinoxe reverse tray adapter plate tray +0; (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit; (b)(6), 320-15-05 - eq rev locking screw; (b)(6), 320-20-22 - eq rev compress screw lck cap kit, 4.5 x 22mm; (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; (b)(6), 320-02-38 - rs expanded glenosphere 38mm, +4mm offset; (b)(6), 320-15-01 - eq rev glenoid plate; (b)(6), 320-20-00 - eq reverse torque defining screw kit.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h3 -.The cause of the patient¿s shoulder dislocation and subsequent revision reported cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Dislocation is a known risks, as outlined in the ifu.H6 - investigation type, findings, conclusion codes.The following sections were corrected: h6 - investigation type, findings, conclusion codes.

• Brand Name: EQUINOXE
• 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 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21684548
• Report Number: 1038671-2025-01650
• Device Sequence Number: 8849552
• Product Code: KWT
• UDI-Device Identifier: 10885862086662
• UDI-Public: 10885862086662
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 320-38-03
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 04/29/2025
• Date Device Manufactured: 10/28/2024
• 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 H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown