MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL LINER, 40MM, +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	320-40-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the equinoxe shoulder study, approximately 0 year(s) and 1 month(s) post-operative of a left implanted tsa, the patient presented with deep infection.For a duration of 2-1/2 months post operatively, the patient had wound dehiscence and was taken to or for irrigation and debridement, culture positive for mrsa.This outcome of the event is reported to be resolved by irrigation and debridement performed for mrsa infection, along with exchange of the polyethylene liner in the left shoulder.The clinical report indicates that the event is definitely related to the device(s) and/or to the procedure.This event report was received through clinical data collection activities and no device return is anticipated.
Additional Manufacturer Narrative
(d10) concomitant device(s): 300-30-06 - equinoxe preserve stem 6mm: 6655852.320-10-00 - equinoxe reverse tray adapter plate tray +0: 6476782.320-31-40 - glenosphere, 40mm: 6579581.320-35-07 - small superior/posterior aug glenoid plate,left: 6654229.320-15-05 - eq rev locking screw: 6693096.320-20-00 - eq reverse torque defining screw kit: 6710244.320-20-26 - eq rev compress screw lck cap kit, 4.5 x 26mm: s067171.320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm: 6329246.320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm: s126038.320-20-46 - eq rev compress screw lck cap kit, 4.5 x 46mm: 5772189.321-20-00 - equinoxe reverse shoulder drill kit: 6784213.
Additional Manufacturer Narrative
A review of the sterile certificates and/or the final endotoxin test reports was performed.All lots were accepted to the requirements.The reason for the reported revision due to suspected infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or the surgical procedure.H6: corrected investigation clinical codes.

• Brand Name: EQUINOXE HUMERAL LINER, 40MM, +0
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 19570589
• Report Number: 1038671-2024-02013
• Device Sequence Number: 20409622
• Product Code: PHX
• UDI-Device Identifier: 10885862535030
• UDI-Public: 10885862535030
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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 Expiration Date: 05/26/2025
• Device Catalogue Number: 320-40-00
• 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: 06/10/2024
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 05/28/2020
• 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 H11
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 167 KG
• Patient Race: White