MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH OPTETRAK SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER, META

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

Patient Problems Fall (1848); Joint Swelling (2356)

Event Date 07/11/2017

Event Type  Injury  

Event Description

Exactech optetrak system installed.Recovery as normal and acceptable general use until earlier this year.Knee stays swollen, slips out of position, have fallen when it locks up and now surgeon says i need to go in for a replacement.Fda safety report id# (b)(4).

• Brand Name: EXACTECH OPTETRAK SYSTEM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER, META
• Manufacturer (Section D): EXACTECH, INC.
• MDR Report Key: 9234574
• MDR Text Key: 163973489
• Report Number: MW5090628
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 66 YR
• Patient Weight: 94