MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE, HUMERAL LONG STEM 8MM 175MM

Model Number	UNKNOWN
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
Pending revision due to infection.The patient did not finish their course of antibiotics and is infected.
Additional Manufacturer Narrative
The engineering evaluation reported in experience was likely the result of infection likely due to the patient not finishing the course of antibiotics.Any ¿surgical site¿ infection noted in a patient that is greater than 3 months postop from a total joint surgical procedure is highly unlikely to be related to the surgical procedure for placement of the total joint or the device itself [1].Acute infection in total knee arthroplasty: diagnosis and treatment juan carlos martínez-pastor, francisco maculé-beneyto, and santiago suso-vergara author information article notes copyright and license information disclaimer open orthop j.2013; 7: 197¿204.Published online 2013 jun 14.Superficial or deep infection are listed in the general surgical risks section of the equinoxe shoulder system ifu 700-096-060.Contraindicated patients include, but are not limited to the patient is unwilling or unable to comply with the post-operative care instructions.

• Brand Name: EQUINOXE
• Common Device Name: EQUINOXE, HUMERAL LONG STEM 8MM 175MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8478064
• Report Number: 1038671-2019-00215
• Device Sequence Number: 1104323
• Product Code: KWT
• UDI-Device Identifier: 10885862083784
• UDI-Public: 10885862083784
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: UNKNOWN
• Device Catalogue Number: 306-01-08
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 94