MAUDE Adverse Event Report: Exactech, Inc. EQUINOXE CAGE GLENOID L, POST AUG, RIGHT; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Catalog Number	314-13-34
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Erosion (1750)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left total shoulder arthroplasty.Subsequently, it was reported that the patient experienced erosion and prosthesis fracture.As a result, the patient will require surgical intervention on a future date.No further patient impact reported.No further information available.

• Brand Name: EQUINOXE CAGE GLENOID L, POST AUG, RIGHT
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 50544602
• Report Number: 1038671-2026-01121
• Device Sequence Number: 10376667
• Product Code: KWS
• UDI-Device Identifier: 10885862201027
• UDI-Public: 10885862201027
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 03/03/2024
• Device Catalogue Number: 314-13-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 03/06/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male