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 Code	Failure of Implant (1924)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, male patient had a cage glenoid revision due to poly fracture and metalosis.There were fragments, parts or pieces removed from patient due to the fractured poly.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.Photos & x-rays received, the device is available for evaluation.
Additional Manufacturer Narrative
Concomitant products: - equinox square torque define screw drive kit (cat# 300-20-02 / serial# (b)(4)); - 4.5mm short rep plate (cat# 300-50-45 / serial# (b)(4)); - equinoxe, humeral head, extra short, 53mm (cat# 310-00-53 / serial# (b)(4)).Additional information, including the product investigation, will be submitted within 30 days of receipt.
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 the center cage sitting proud at the time of implantation, leading to disassociation of the cage from the polyethylene body, and extensive abrasive backside wear of the polyethylene in the posterior, superior region.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 is associated with incorrect assembly of the device or constituents by the users.

• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16488096
• Report Number: 1038671-2023-00359
• Device Sequence Number: 6758455
• Product Code: KWT
• UDI-Device Identifier: 10885862172723
• UDI-Public: 10885862172723
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: 01/02/2021
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male