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

Catalog Number	314-13-03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
No known event occurred.Patient presented to the clinic with pain & loss of function.Imaging indicated a failed glenoid component.It is unclear if any specific event led to the failure.The humeral head, replicator plate, torque defining screw, & glenoid component were explanted.The glenoid component was completely dissociated from the glenoid bone.All three peripheral pegs remained on the glenoid component.The central cage was still in the bone & was explanted with the cage removal tool.The glenoid was observed to have significant bone loss, leading the surgeon to opt for a hemi prosthesis & bone graft for the glenoid defect.He used a new replicator plate, torque defining screw, & humeral head from exactech, along with opteform rt & & cancellous chips for the glenoid.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6), 300-01-11 - equinoxe, humeral stem primary, press fit 11mm, (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), 310-01-44 - equinoxe, humeral head short, 44mm (alpha), (b)(6), 321-20-00 - equinoxe reverse shoulder drill kit.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, g.The revision reported was likely the result of prosthesis fracture resulting in the migration and subsequent wear of the glenoid component.The cause of the fracture may be due to incomplete seating of the implant and/or off-axis drilling of the peg holes during implantation resulting in a rocking horse effect.The bone loss around the glenoid could have been a contributing factor to the migration of the glenoid component.However, the series of events could not be confirmed as the devices were not returned for evaluation.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 MEDIUM, ALPHA
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 19729001
• Report Number: 1038671-2024-02375
• Device Sequence Number: 8275415
• Product Code: KWS
• UDI-Device Identifier: 10885862172686
• UDI-Public: 10885862172686
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: 08/01/2023
• Device Catalogue Number: 314-13-03
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2018
• 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): Yes
• 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 Sex: Male