MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL TRAY +15MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-10-15
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that this device did not cause or contribute to the reported event.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.
Additional Manufacturer Narrative
D10: 320-20-00 - eq reverse torque defining screw kit: b681278.322-46-13 - 145-deg pe 46mm const hum liner +2.5: b196542.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a male patient, who had a right rtsa, underwent a revision procedure.The locking screw came out of the sphere.The sphere, tray, poly, and locking screw were revised with new implants.There were no device breakages during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted device is not available for return due to hospital policies.No further information this is 1 of 3 reports for this event.This is 1 of 2 events for this patient.

• Brand Name: EQUINOXE HUMERAL TRAY +15MM
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-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: 23866621
• Report Number: 1038671-2025-03596
• Device Sequence Number: 5344306
• Product Code: KWS
• UDI-Device Identifier: 10885862086440
• UDI-Public: 10885862086440
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• 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): 12/31/2025

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: 320-10-15
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2023
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male