MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOSPHERE, 36MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-31-36
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient, who had a left rtsa, underwent a revision procedure due to a loose glenoid.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were provided.The explanted device is available for return.No device images were provided.No further information.
Additional Manufacturer Narrative
D10: 300-01-11 - eq, hum stem prim, press fit 11mm: (b)(6), 320-15-05 - eq rev locking screw: (b)(6), 320-20-00 - eq rev torq defining screw kit: (b)(6), 320-20-18 - eq rev comp scr lck cap kit, 4.5 x 18mm: (b)(6), 320-20-18 - eq rev comp scr lck cap kit, 4.5 x 18mm: (b)(6), 320-20-22 - eq rev comp scr lck cap kit, 4.5 x 22mm: (b)(6), 320-20-26 - eq rev comp scr lck cap kit, 4.5 x 26mm: (b)(6), 321-52-09 - 3.2mm k-wire, trocar tip: (b)(6), 322-10-00 - humeral adapter tray, +0: (b)(6), 322-36-00 - 145-deg pe 36mm hum liner +0: (b)(6), 320-35-01 - small glenoid plate: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: EQUINOXE GLENOSPHERE, 36MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 24464173
• Report Number: 1038671-2026-00201
• Device Sequence Number: 9620980
• Product Code: PHX
• UDI-Device Identifier: 10885862534866
• UDI-Public: 10885862534866
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 02/26/2026

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: 320-31-36
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2025
• 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: Hospitalization; Required Intervention
• Patient Sex: Female