MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 3, 9MM, SLOPE +; SEE H10

Model Number 200-63-09

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 07/25/2017

Event Type  Injury  

Event Description

Additional information received by the legal department on 28 feb 2023: on (b)(6) 2012, the patient underwent a right total knee replacement with an exactech knee device.On (b)(6) 2017, approximately 5 years later the patient underwent revision of the right exactech knee device secondary to significant polyethylene liner wear with resulting metallosis, osteolysis, and synovitis.It is also stated that despite undergoing the revision surgery, the patient experiences daily knee pain and discomfort which limit activities of daily living and recreation and impacts quality of life.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

Manufacturer Narrative

Procodes: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: 2350164 200-02-35 - three peg patella 35mm; 2199224 204-04-33 - trapezoid tibial tray sz 3f/3t; 1304943 230-03-03 - optetrak asy,cr cemented femoral, sz 3.Follow up type: initial and fu1 fda mdr reported under mfr# 1038671-2017-00535, this is being filed, with additional information and this is from a historical case before electronic complaint handling system.

• Brand Name: CR TIBIAL INSERT SZ 3, 9MM, SLOPE +
• Type of Device: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16617465
• MDR Text Key: 312010353
• Report Number: 1038671-2023-00513
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2013
• Device Model Number: 200-63-09
• Device Catalogue Number: 200-63-09
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/27/2023
• Date Device Manufactured: 12/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0019-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention