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

Model Number	EQUINOXE CAGE GLENOID EXTRA LARGE, BETA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: - equinoxe, humeral stem primary, press fit 15mm (cat# 300-01-15 / serial# (b)(4).- equinoxe replicator plate 4.5mm o/s (cat# 300-10-45 / serial# (b)(4).- equinoxe, humeral head short, 50mm (beta) (cat# 310-01-50 / serial# (b)(4).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately seven years post initial tsa, the male patient had a revision of cage glenoid due to prosthesis fracture.Revised on (b)(6) 2023 to a reverse.All components removed.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.The device is available for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the revision reported was likely the result of disassociation of the center cage from the polyethylene body.This may have occurred due to off-axis drilling or incomplete seating of the cage glenoid during implantation.However, this cannot be confirmed because no original post-operative or pre-revision radiographs were provided.The most probable root cause associated with the reported event of ¿prosthesis fracture¿ is associated with a partial or full-thickness crack in the device materials, either during implantation or sometime after.Do not use if broken device is a screw.

• Brand Name: EQUINOXE CAGE GLENOID EXTRA LARGE, BETA
• Common Device Name: PROSTHESIS, SHOULDER, NON-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 ; 3523771140
• MDR Report Key: 16704092
• Report Number: 1038671-2023-00622
• Device Sequence Number: 20234992
• Product Code: KWT
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 09/24/2026

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: 03/15/2020
• Device Model Number: EQUINOXE CAGE GLENOID EXTRA LARGE, BETA
• Device Catalogue Number: 314-13-15
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2023
• Supplement Date Received by Manufacturer: 05/12/2023; 09/24/2026
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/13/2023; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• 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: Required Intervention
• Patient Sex: Male