MAUDE Adverse Event Report: EXACTECH, INC. EQ REV GLENOID PLATE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	02/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-01-13 - equinoxe, humeral stem primary, press fit 13mm: 5710508.320-01-42 - equinoxe reverse 42mm glenosphere: 5884751.320-10-00 - equinoxe reverse tray adapter plate tray +0: 5882520.320-15-05 - eq rev locking screw: 5827971.320-20-00 - eq reverse torque defining screw kit: 5884259.320-20-18 - eq rev compress screw lck cap kit, 4.5 x 18mm: 5826540.320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm: 5885855.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: 5771283.320-42-00 - equinoxe reverse 42mm humeral liner +0: 5897736.321-20-00 - equinoxe reverse shoulder drill kit: 5029152.
Event or Problem Description
As reported by the equinoxe shoulder study, the 63-year-old male patient had an initial right tsa on (b)(6)2019 and presented with acromial fracture/stress fracture, 0 year(s) and 11 month(s) post initial procedure on (b)(6)2020.The outcome of this event is considered unknown and no action was taken.The case report form indicates that this event is possibly related to the device and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
H6: corrected health effect, component, and investigation clinical codes.The reason for the post operative bone fracture reported in case-(b)(4) cannot be conclusively determined but may be related to implant positioning, patient bone quality, a trauma, and/or another patient related condition.However, this cannot be confirmed based on the information provided.

• Brand Name: EQ REV GLENOID PLATE
• 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; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18763222
• Report Number: 1038671-2024-00305
• Device Sequence Number: 4387767
• Product Code: KWT
• UDI-Device Identifier: 10885862086488
• UDI-Public: 10885862086488
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 320-15-01
• 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: 01/20/2024
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2018
• 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 H10.
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Race: White