MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK UNICONDYLAR FEMORAL COMPONENT, CEMENTED

Catalog Number 250-01-03

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

Patient Problems Pain (1994); Swelling (2091)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.

Event Description

Index surgery: (b)(6) 2016.In (b)(6) of 2017, patient presented with increased pain and swelling in the left knee, possible chondromalacia.Patient is also having difficulties with her right knee that had a replacement, which is causing her left knee to compensate.Actions taken: medication, steroid injection, ice and elevation.The adverse event form indicates this event is definitely not related to devices.This event report was received through clinical data collection activities.

Manufacturer Narrative

The patient has a comorbidity of obesity; one contraindication for the use of this product states weight, age, or activity level might cause extreme loads and early failure of the system.This patient has bilateral knee replacement, which indicates a history of chronic knee pain and treatments.The knee systems are contraindicated in the following situations: patients with suspected or confirmed systemic infection or a secondary remote infection; patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis; patients without sufficient soft tissue integrity to provide adequate stability; patients with either mental or neuromuscular disorders that do not allow control of the knee joint; patients whose weight, age, or activity level might cause extreme loads and early failure of the system.Event date was reported as (b)(6) 2017.

Event Description

Associated mfrs for this event: 103867-2017-00266, 103867-2017-00267, 103867-2017-00268, 103867-2017-00269, and 103867-2017-00270.

• Brand Name: OPTETRAK UNICONDYLAR FEMORAL COMPONENT, CEMENTED
• Type of Device: FEMORAL COMPONENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 6554395
• MDR Text Key: 74740476
• Report Number: 1038671-2017-00266
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 250-01-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 102