MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.D10 conomitants: (b)(6), 200-02-32 - three peg patella 32mm.(b)(6), 204-04-22 - trapezoid tibial tray sz 1f/2t, 2f/2t.(b)(6), 244-02-02 - optetrak asy hi-flex ps cem fem, sz 2, left.
Event or Problem Description
Legal case ¿ usa.Patient id: (b)(6).Case-(b)(4).Case-(b)(4).***additional information received from legal on 14-nov-2023 4 jan 2024, (b)(6) , rn- implant date: (b)(6) 2010, , op report attached / explant date: (b)(6) 2016: postoperative diagnosis: synovitis, with aseptic loosening; open debridement and synovectomy with revision of all 3 components.Revised to exactech devices.The patient was awakened and taken to recovery in stable condition.Revision op report attached.***original description summary*** as reported via legal documentation the patient had a left knee replacement on (b)(6) 2010.Approximately 6 years and 6 months after the initial procedure the patient had the first left knee revision.After each of the left total knee replacement surgeries, the patient began to suffer from symptoms including but not limited so synovitis with aseptic loosening, mechanical loosening, pain and lack of mobility.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.The device, optetrak hi-flex tibial insert, serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
B4: corrected.
Event or Problem Description
As reported via legal documentation the patient had a left knee replacement on (b)(6) 2010.Approximately 6 years and 6 months after the initial procedure the patient had the first left knee revision.After each of the left total knee replacement surgeries, the patient began to suffer from symptoms including but not limited so synovitis with aseptic loosening, mechanical loosening, pain and lack of mobility.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.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21233372
• Report Number: 1038671-2025-00405
• Device Sequence Number: 18300153
• Product Code: JWH
• UDI-Device Identifier: 10885862063953
• UDI-Public: 10885862063953
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 04/25/2015
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT, SZ 2, 9MM
• Device Catalogue Number: 244-22-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/11/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/03/2025
• Date Device Manufactured: 04/26/2010
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Female