MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL LINER, 40MM, +2.5

Model Number	320-40-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.Concomitant medical products: 320-32-40 - expanded glenosphere, 40mm, for small reverse.300-30-12 - equinoxe preserve stem 12mm.320-10-10 - equinoxe reverse tray adapter plate tray +10 reverse glenosphere baseplate.
Event or Problem Description
As reported by equinoxe shoulder study, approximately 2 months post op the initial tsa, this (b)(6) male patient experienced redness and swelling to his proximal infection.He also had surgical removal of a haematoma.The case report form indicates this event is definitely not related to devices and definitely related to procedure.This event report was received through clinical data collection activities.
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 the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL LINER, 40MM, +2.5
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14632636
• Report Number: 1038671-2022-00652
• Device Sequence Number: 3914300
• Product Code: KWT
• UDI-Device Identifier: 10885862535047
• UDI-Public: 10885862535047
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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 Model Number: 320-40-03
• Device Catalogue Number: 320-40-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White