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

Catalog Number	320-15-05
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the surgeon noticed the glenosphere screw was loose with the end disengaged during a left shoulder scope necessitating a revision.During the revision, the baseplate and stem were found to be well fixed.The liner tray and glenosphere were replaced.Cultures came back negative for infection.The patient was revised to exactech devices.The event was not associated with the breakage of a device.The event did not cause a surgical delay/prolongation.Patient was last known to be in stable condition following the event.X-rays were unable to be obtained.No device return for analysis anticipated due to the hospital kept the device.Device images were provided.
Additional Manufacturer Narrative
D10: concomitants: 82085014 320-01-38 38 glenosphere; 80962004 320-10-00 +0 adapter tray ; 320-20-00 fixed angle torque screw; 38 +0 liner.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: a, b, c, d, g.The revision reported was likely the result of glenosphere locking screw fracture and prosthesis wear of the humeral liner.The cause of the fracture cannot be determined but may be related to improper initial seating of the glenosphere, soft tissue/bone interposition, and/or an unreported traumatic event.The observed wear on the liner appears consistent with a combination of impingement between the liner and native glenoid bone and abnormal articulation with the glenosphere and/or locking screw following the screw fracture.However, the series of events cannot be confirmed and potential contributions of user or patient-related considerations could not be assessed as the devices were not returned for evaluation and no radiographs or relevant clinical information was provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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 32653 ; 3525541928
• MDR Report Key: 19742843
• Report Number: 1038671-2024-02392
• Device Sequence Number: 17047935
• Product Code: KWT
• UDI-Device Identifier: 10885862086495
• UDI-Public: 10885862086495
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 10/14/2025

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: 320-15-05
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female