MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; 1.5MM SHORT REP PLATE

Catalog Number 300-50-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Pending revision due to infection.The patient did not finish their course of antibiotics and is infected.

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-vergaraauthor information article notes copyright and license information disclaimeropen 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
• Type of Device: 1.5MM SHORT REP PLATE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8478000
• MDR Text Key: 140766687
• Report Number: 1038671-2019-00213
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862210791
• UDI-Public: 10885862210791
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300-50-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 94