MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK TIBIAL INSERT, CRUCIATE RETAINED

Catalog Number 200-25-09

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2017.Revision due to pain.Pending evaluation.

Manufacturer Narrative

Revision never took place.

Event Description

Revision never took place.

Manufacturer Narrative

Void revision never took place.

Event Description

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

Manufacturer Narrative

The complaint product was received for analysis.The reported product condition of prosthesis wear is confirmed.Visual evaluation condition findings (conducted with a 7x or 10x optical).Superior surface of tibial insert: the pitting/delamination appears consistent with third body wear.The darker stained portions of the tibial inserts appear consistent with metal debris, which may have resulted from metal on metal articulation between the femoral component and the tibial tray.Underside of tibial insert shows cracks that appear consistent with excessive stress on the articular surface of the tibial insert propagating to the inferior surface.Tibial tray: the worn lateral edge of the tibial tray appears consistent with articulation with a lateral femoral condyle.The frequency of occurrence ranking scale is very low; therefore, this issue does not appear to be design-related.The company is not aware of any other complaints involving parts from any of these manufacturing lots.According to the sales data, all pieces from the lot of tibial inserts have been sold.This implies all other pieces have been successfully implanted.The device history record for the tibial insert component was reviewed, and all parts were accepted with conformance to the print specifications.Therefore, this issue does not appear to be manufacturing-related.There are no reported user-related issues.The revision reported was likely the result of excessive overall posterior tibial slope and/or substantial axial rotation misalignment between the femoral component and the tibial tray, which allowed for excessive posterior contact between the femoral component and the tibial insert on the lateral aspect leading to catastrophic wear of the uhmwpe tibial insert.In review of the labeling knee systems are contraindicated in the following situations: patients whose weight, age, or activity level might cause extreme loads and early failure of the system.There are also risks that may lead to second surgical interventions or revisions.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.Device specific risks include: fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, any of which may require a second surgical intervention or revision.It is also noted that excessive wear of the implant components secondary to impingement of components or damage of articular surfaces may cause revision.There is no patient information provided; therefore, it is not possible to assess the patient risk/clinical factors this device is used for treatment not diagnosis.For blocks with no information, asked not provided.Corrected information: this event did result in a surgical revision and is being properly reported.

Event Description

It was reported from japan that a patient experienced a tibial insert and tibial tray revision due to pain.The patient had an arthroscopic procedure on (b)(6) 2018 that identified the following issues: medial articulating surface turned yellowish; delamination; anterior medial insert loss was observed, and some of the delamination was removed.No additional information was provided about the event or patient.This is one of three products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00604 and 1038671-2018-00605.

• Brand Name: OPTETRAK TIBIAL INSERT, CRUCIATE RETAINED
• Type of Device: OPTETRAK TIBIAL INSERT, CRUCIATE RETAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7698243
• MDR Text Key: 114314058
• Report Number: 1038671-2018-00603
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K932776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2017
• Device Catalogue Number: 200-25-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Date Manufacturer Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention