MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK TIBIAL STEM EXTENSION SCREW

Catalog Number 204-70-00

Device Problems Failure To Adhere Or Bond (1031); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Adhesion(s) (1695); Joint Disorder (2373)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Index surgery: (b)(6) 2011.Revision due to aseptic loosening of the femoral component and possible loosening of the tibial tray component.

Event Description

No additional information about the patient or the event has been provided.This is one of five products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00489, 1038671-2018-00531, 1038671-2018-00532, 1038671-2018-00533.

Manufacturer Narrative

The complaint product was received for analysis.The reported experience of loosening is confirmed.Visual evaluation condition/findings (conducted with a 7x or 10x optical) tibial insert has noticeable indentations on the tibial insert that appear consistent with the complaint of loosening.Stem extension - noticeable indentations on the stem extension appear consistent with the complaint of loosening, which likely caused device-device wear.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 complaint reports involving parts from this manufacturing lot since 2014.A review of the device history record showed that the named devices were accepted with conformance to the device requirements.Therefore, this does not appear to be manufacturing-related.There are no user-related issues reported.The loosening reported was likely the result of micromotion caused by an insufficient bond between the femoral component and the bone cement, which led to aseptic femoral loosening.Micromotion at the tibial component may have also caused loosening of the tibial tray.In a review of the labeling it is a known complication that excessive activity and trauma affecting joint replacements have been associated with premature failure and that fracture, migration, loosening, subluxation, or dislocation of the prosthesis or any of its components, may require a second surgical intervention or revision.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.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.

• Brand Name: OPTETRAK TIBIAL STEM EXTENSION SCREW
• Type of Device: OPTETRAK TIBIAL STEM EXTENSION SCREW
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• MDR Report Key: 7633716
• MDR Text Key: 112167422
• Report Number: 1038671-2018-00534
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: K933610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/10/2016
• Device Catalogue Number: 204-70-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR