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

Catalog Number 200-23-11

Device Problems Degraded (1153); Deformation Due to Compressive Stress (2889)

Patient Problem Joint Disorder (2373)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

The complained products were no received for analysis.The reported malfunction of prosthesis wear was not confirmed.The frequency of occurrence ranking scale is very low; therefore, this does not appear to be design-related.The company is not aware of receiving any other complaint reports involving parts from this manufacturing lot of tibial inserts.The device history record was reviewed, and all parts were accepted with conformance to the print specifications.Therefore, this issue does not appear to be manufacturing-related.There were no user-related conditions reported.The revision reported was likely the result of excessive tibial insert 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.In review of labeling, op techs and ifus: 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.Metal sensitivity reactions or other allergic/histological reactions to implant materials; possible detachment of the coating(s) on the components, potentially leading to increased debris particles; adverse events associated with the use of bone cement; disassociation of modular components; & excessive wear of the implant components secondary to impingement of components or damage of articular surfaces.It is a known complication that a patient's age, weight, or activity level would cause the surgeon to expect early failure of the system.The patient risk/clinical factors include the fact that the patient is young and has bilateral knee arthroplasties which causes a stress on the devices from a biomechanical standpoint.There are underlying patient conditions such as joint maladies also evidenced by bilateral tka at (b)(6) years of age.This device is used for treatment not diagnosis.Information has been requested on the event and patient.No new information has been provided.

Event Description

It was reported that a patient experienced a left knee revision due to prosthesis wear.The patient had developed mechanical symptoms in his knee joint and his radiographs demonstrated evidence of subluxation of his femur on his tibia consistent with wear of the polyethylene liner.In surgery, it was found that the polyethylene liner had worn in the posteromedial corner such that the femoral and the tibial components for rubbing against one another causing the metallosis, the entire knee replacement had to be revised.The parapatellar capsule was opened, it was evident that the patient had a significant amount of metallosis within the knee joint that was covering the entire synovium.The fluid was sent for gram stain, culture and sensitivity, although there was no evidence of infection (the results were not provided).An extensive synovectomy was performed starting in the medial gutter, extending into the suprapatellar pouch, and then into the lateral gutter, the infrapatellar tendon was also debrided.The patient tolerated the procedure well and postoperatively was transferred to the recovery room in satisfactory condition.There were no complications.No additional information was provided about the patient or event.This is one of six products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00100, 1038671-2017-00467, 1038671-2017-00469, 1038671-2017-00470, 1038671-2017-00471 and 1038671-2019-05028.

• Brand Name: OPTETRAK TIBIAL INSERT, CRUCIATE RETAINED
• Type of Device: TIBIAL INSERT
• Manufacturer (Section D): EXACTECH, INC; 2320 nw 66th court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 8562392
• MDR Text Key: 143536600
• Report Number: 1038671-2019-05028
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/06/2011
• Device Catalogue Number: 200-23-11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2006
• 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: 55 YR