MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, BETA; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-13-13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patients right shoulder was revised.Patient had a failed anatomic converted to reverse shoulder arthroplasty.Surgeon kept stem, used a zero tray and liner, and used a competitors glenoid and glenosphere.Glenoid was fractured, removed all fragments.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10 concomitant devices: (b)(6), 1510-s - cemex system fast 70 gm, (b)(6), 300-20-02 - equinox square torque define screw drive kit, (b)(6), 300-30-10 - equinoxe preserve stem 10mm, (b)(6), 300-50-45 - 4.5mm short rep plate, (b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta), (b)(6), 315-35-00 - glnd kwire.(b)(6) - sterile disposable containers.H3: 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.[[insert manufacturing review statement]] 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.
Additional Manufacturer Narrative
The revision reported may be the result of the glenoid fracture as reported.The glenoid was reported to be fractured but no other description of the device was provided and radiographs and images were not available.Contributing factors to the reported fracture may include a combination of articular surface wear and thinning of the glenoid body, incomplete seating, and/or eccentric loading around a well-fixed center cage with loosening of the peripheral pegs may have led to the fracture but this cannot be confirmed from the information provided.Potential contributions of manufacturing, patient, or user-related issues to the event cannot be determined from the reported information.

• Brand Name: EQUINOXE CAGE GLENOID MEDIUM, BETA
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21080829
• Report Number: 1038671-2025-00088
• Device Sequence Number: 6765581
• Product Code: KWS
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/16/2025

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 Expiration Date: 01/28/2021
• Device Catalogue Number: 314-13-13
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 02/01/2016
• 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 Age: 62 YR
• Patient Sex: Male