MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM HUMERAL CONST LINER +2.5

Model Number	320-42-13
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-20-00, 7272969 - eq reverse torque defining screw kit.300-30-07, 7216415 - equinoxe preserve stem 7mm.320-10-00, 7066657 - equinoxe reverse tray adapter plate tray +0.320-15-05, 7246544 - eq rev locking screw.320-06-42, 7219545 - glenosphere 42mm.
Event or Problem Description
Between revision on 4/13 and 4/26, patient had reverse shoulder surgery on (b)(6) 2022.On (b)(6) 2022, patient had revision due to an infection at the wound site.Humeral liner was upsized to a 42mm +2.5 constrained.An experience report was submitted on (b)(6) 2022.On (b)(6) 2022 patient had another revision due to suspected infection.Surgeon exchanged stem, glenosphere, adapter plate tray and humeral liner.First revision is captured in (b)(6) / mdr# 1038671-2022-00525.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the previous surgical site infection.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 42MM HUMERAL CONST LINER +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson kate jacobson ; 3523771140
• MDR Report Key: 14491062
• Report Number: 1038671-2022-00600
• Device Sequence Number: 4735765
• Product Code: KWT
• UDI-Device Identifier: 10885862086723
• UDI-Public: 10885862086723
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2024
• Device Model Number: 320-42-13
• Device Catalogue Number: 320-42-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male