MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-02-26
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: logic cf femur sz 2 cemented.02-012-45-2030, logic tibia cemented fit tray 2f/3t.No device was returned for evaluation; radiograph and device images were provided; however, the reported event was unable to be confirmed.The review of pre-revision images identified a diminished gap distance between the femoral and tibial components on the medial aspect as compared to the lateral aspect.This may be consistent with medial articular surface wear.The tibial insert image review indicated the medial aspect of the articular surface appears to have undergone fatigue wear with subsurface propagation of shear cracking prior to the eventual surface layer delamination and pitting of the articular surfaces.Fatigue wear, and particularly delamination, occurs secondary to cyclic shear stress between the tibial and femoral components.The lateral aspect appears unremarkable in the provided images and images of the backside of the insert were not provided.The explanted patellar component has evidence of articular surface wear and damage due to device explantation.Patellar wear most often occurs secondary to lateral tracking of the patella and contact with the trochlear ridge of the femoral component.Patellar maltracking following knee arthroplasty may occur secondary to a number of factors including pre-existing patellar maltracking, implant positioning, patellar thickness, obesity, and/or a tight lateral retinaculum.A review of complaint history determined that no further action is required as no trends were identified.The revision reported was likely the result of prosthesis wear of their tibial insert and patellar components.Another contributing factor to the revision may include instability, as reported; however, this instability could not be confirmed.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
As reported, approximately 7 years post op the initial right tka, this 73 y/o female patient was revised due to complaints of pain, swelling, instability, and dissatisfaction.The patient has a recalled implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient had revision surgery on (b)(6)2023.The patient underwent a right tka tibial poly swap and patella implant swap.The patient left the or stable following full revision.Devices are not returning; the implant is required to go to the lab and legal at the hospital.This is 1 of 2 reports for this event.

• Brand Name: OPTETRAK
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24839877
• Report Number: 1038671-2026-00412
• Device Sequence Number: 9532187
• Product Code: JWH
• UDI-Device Identifier: 10885862039576
• UDI-Public: 10885862039576
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K932690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: 05/11/2020
• Device Catalogue Number: 200-02-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/10/2026
• Date Device Manufactured: 05/14/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 97 KG