MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIAL INSERT, SIZE 5, 9MM

Catalog Number 02-012-35-5009

Device Problems Fracture (1260); Pitted (1460)

Patient Problems Unspecified Infection (1930); Joint Disorder (2373); Post Operative Wound Infection (2446)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision as a result of an acute infection caused by a femoral fracture and tibial fracture.

Event Description

It was reported that a patient experienced a poly swap for an acute infection.The initial surgery date was not reported.The patient had a femoral fracture and an open reduction internal fixation (orif) was performed then on a separate occasion the patient suffered a peri prosthetic tibial fracture.Following the tibial orif an acute infection was diagnosed.There is no indication of device problem or malfunction.There is no additional information provided about the patient or event.

Manufacturer Narrative

This is a clinical event with no reasonable relationship to the infection or noted device malfunction.Visual evaluation condition/findings (conducted with a 7x or 10x optical ) poly wear was found on the device; however, it was not the cause of revision surgery.The proximal surface of the returned tibial insert showed scratching and pitting that appears consistent with third body wear.Third body wear occurs when a third body, such as a fragment of bone cement, gets trapped between the polyethylene insert and the condyles of the femoral component.As the patient moves, the third body can create scratches, and sometimes pitting, on the surface of the insert.The pitting of the tibial insert spine does not appear consistent with typical wear associated with articulation.The pitting was likely created by excessive bone cement from the femoral component contacting the tibial insert as the components articulated.According to the experience report, the reported infection is attributed to this event.However, there is no information provided regarding lab tests or lab results to confirm this diagnosis.In a review of the labeling - it is a known complication that infection, both deep and superficial may require a second surgical intervention or revision.Also, as part of the pre-operative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or the postoperative period.Revisions or surgical interventions are a known complication found in joint replacements.All patients should be instructed on the limitations of the prosthesis, the patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment.This device is used for treatment not diagnosis.Information about the patient and event have been requested; no new information was provided.

• Brand Name: LOGIC TIBIAL INSERT, SIZE 5, 9MM
• Type of Device: TIBIAL INSERT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7703184
• MDR Text Key: 114457124
• Report Number: 1038671-2018-00612
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K033883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2021
• Device Catalogue Number: 02-012-35-5009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention