MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	OPTETRAK LOGIC COMPONENTS
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Adhesion(s) (1695); Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint effusion (4849)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the legal brief, on or about (b)(6) 2016 patient underwent a right total knee replacement and was implanted with an exactech optetrak logic comprehensive total knee replacement.On or about (b)(6) 2022, patient underwent a revision surgery on her right knee for issues including but not limited to polyethylene wear, bone loss, osteolysis, and/or instability.Patient¿s medical records reflect the typical findings of accelerated and preventable polyethylene wear due to defective design of the device and a manufacturing defect of the device which produced toxic polyethylene particles and debris, resulting in premature catastrophic failure and revision surgery.
Event or Problem Description
57 y/o female patient had a right knee revision on (b)(6) 2022 due to pain, swelling and stiffness.This is approximately 5 years and 11 months after the patient's initial right knee replacement.Imaging studies demonstrate particulate debris-induced synovitis.There is no extensive osteolysis based on preoperative imaging.The patient has persistent pain and swelling and is thus indicated for polyethylene liner exchange.Findings: at the time of surgery, there was found to be an effusion.These was moderately inflamed synovium.There were no signs of infection.Femoral, tibial and patellar components were all well fixed.There was extensive pseudomembrane and scar formation.The patient was brought to recovery in stable condition.
Additional Manufacturer Narrative
As a result of the investigation, the following fields have been update: a2, a4, b5, b6, b7, d1, d4, d8, g4, h4, h6, h7, and h9.H6: investigation results - the revision reported was likely the result of prosthesis wear.The extent and root cause of the prosthesis wear could not be confirmed as the device was not returned for evaluation, and images and radiographs were not provided.

• Brand Name: CC TIBIAL INSERT SZ 4, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16448625
• Report Number: 1038671-2023-00252
• Device Sequence Number: 20301536
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2017
• Device Model Number: OPTETRAK LOGIC COMPONENTS
• Device Catalogue Number: 208-24-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 09/14/2026
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 09/29/2023; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 244 LB