MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK UNICONDYLAR TIBIAL COMPONENT, ALL-POLY LEFT MEDIAL/RIGHT LATERAL

Catalog Number 252-22-05

Device Problems Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Joint Disorder (2373); No Code Available (3191)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision due to poly wear.

Manufacturer Narrative

Postoperative counseling and care is important.It is recommended that regular, long-term postoperative follow-up be undertaken to detect early signs of component wear and loosening, and to consider the course of action to be taken if such events occur.A suitable rehabilitation program should be designed and implemented.A continuing periodic follow-up is recommended.Periodic x-rays should be taken to detect evidence of positional changes, loosening, bone loss, and/or device fracture.In such cases, patients should be monitored, and the benefits of revision surgery should be considered to avoid further deterioration.Upon review of all the available information, was likely the result of unicondylar all poly tibial component wear.The underlying cause of the wear could not be determined because the component was not returned for evaluation and no x-rays were provided.This device is used for treatment, not diagnosis.

Event Description

It was reported that a male patient was implanted with a uni-knee.The patient returned and the uni-knee was replaced during a total knee arthroplasty.It was noted that the uni poly was worn beyond what the surgeon expected for its less than 6 months stay in patient.The patient left the or in stable condition.No other information was reported.This is one of two products involved with the reported event and the associated manufacturer report number is 1038671-2018-00127.

• Brand Name: OPTETRAK UNICONDYLAR TIBIAL COMPONENT, ALL-POLY LEFT MEDIAL/RIGHT LATERAL
• Type of Device: TIBIAL COMPONENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7153967
• MDR Text Key: 96019472
• Report Number: 1038671-2017-00942
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K040889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/12/2018
• Device Catalogue Number: 252-22-05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention