MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID S, POST AUG, RIGHT; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	314-13-32
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A clinical study reported that the patient initially underwent a total shoulder arthroplasty (tsa).Subsequently, the patient experienced dissociation of the polyethylene component.The patient sustained several falls in 2024; however, the relationship between these events and the implant failure cannot be confirmed.In 2025, the patient reported increased shoulder pain, prompting radiographic evaluation, which demonstrated glenoid polyethylene shear failure of the tsa.As a result, the surgeon revised preserve stem, replicator plate, torque screw, humeral head, glenoid.The outcome is considered resolved.No further information is available.
Additional Manufacturer Narrative
D10: 300-30-08 - eq preserve stem 8mm: (b)(6).310-00-47 - xs huml head, 47mm xs offset hum head: (b)(6).300-50-15 - 1.5mm short rep plate: (b)(6).The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: EQUINOXE CAGE GLENOID S, POST AUG, RIGHT
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24365627
• Report Number: 1038671-2026-00162
• Device Sequence Number: 20162457
• Product Code: HSD
• UDI-Device Identifier: 10885862658012
• UDI-Public: 10885862658012
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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 Expiration Date: 01/25/2026
• Device Catalogue Number: 314-13-32
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 01/26/2021
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 150 KG
• Patient Race: White