MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT
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 13mm (cat# 300-01-13 / serial# (b)(4)).Equinoxe replicator plate 4.5mm o/s (cat# 300-10-45 / serial# (b)(4)).Equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(4)).Equinoxe, humeral head short, 53mm (beta) (cat# 310-01-53 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the male patient had right total shoulder arthroplasty (atsa) revised to a reverse total shoulder arthroplasty (rtsa) due to prosthesis fracture.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
The revision reported was likely the result of a shear force exerted on the center cage and center polyethylene peg of the glenoid component, which allowed for the center cage and peg to fracture and detach from the polyethylene body.The shear force was likely due to weakening or complete failure of the patient¿s rotator cuff, which led to superior migration and articulation of the humeral head.Incomplete seating of the glenoid component at the time of implantation may have also played a role in this event, as the inferior posterior peripheral peg hole appears to have been drilled at an angle relative to the other peg holes.The potential incomplete seating and rotator cuff failure cannot be confirmed because no immediate post-operative or pre-revision radiographs were provided for evaluation.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.Also, it is associated with one or more of the rotator cuff muscles becoming weakened or torn following shoulder replacement surgery.
Event or Problem Description
It was reported that the patient underwent an initial right total shoulder arthroplasty.Subsequently, it was reported that the patient experienced a fracture of the cage glenoid.As a result, the patient underwent a right shoulder revision approximately 5 years and 11 months after initial implantation.No further patient impact reported.No further information available.

• Brand Name: EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT
• 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: 16696023
• Report Number: 1038671-2023-00596
• Device Sequence Number: 5670720
• 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: 2017
• 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: 02/07/2021
• Device Model Number: EQUINOXE CAGE GLENOID XL, POST AUG, RIGHT
• Device Catalogue Number: 314-13-35
• 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: 04/06/2023
• 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: 02/09/2016
• 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: ACCELERATE PRP 60 ML & ACD-A.; GLND KWIRE.; PLATELET RICH PLASMA KIT WITH SPRAY TIPS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male