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 Codes	Fracture (1260); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s, (b)(6), 300-20-02 - equinox square torque define screw drive kit, (b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta), (b)(6), 314-13-13 - equinoxe cage glenoid medium, beta, (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit, (b)(6), 300-01-13 - equinoxe, humeral stem primary, press fit 13mm, (b)(6), 300-10-45 - equinoxe replicator plate 4.5mm o/s, (b)(6), 300-20-02 - equinox square torque define screw drive kit, (b)(6), 310-01-47 - equinoxe, humeral head short, 47mm (beta).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported a female patient, initial right shoulder implanted in (b)(6) 2018, underwent a revision procedure, date unknown.The cage glenoid dissociated.The poly has separated from the cage.This caused the patient to have a revision to remove the broken parts.No parts or pieces fell into the wound site.All parts and pieces were removed.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return due to chain of command at the facility.Device images were provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3, d1, d6b, h6.Mdr section codes updated/corrected: b, c, d.The revision reported was likely the result of wear, fracture, and disassembly of the equinoxe cage glenoid.The cause of these failures may be due to incomplete seating of the implant and/or off-axis drilling of the peg holes during implantation leading to a rocking horse effect around a well-fixed cage.However, the series of events could not be confirmed as the devices were not returned for evaluation and no radiographs were provided.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 21462607
• Report Number: 1038671-2025-01216
• Device Sequence Number: 8840302
• Product Code: KWS
• UDI-Device Identifier: 10885862172693
• UDI-Public: 10885862172693
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 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): 10/30/2025

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: 01/01/2023
• 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: 02/06/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 01/03/2018
• 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: 72 YR
• Patient Sex: Female