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

Catalog Number	02-010-03-0350
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Inadequate Osseointegration (2646); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6),02-012-49-5009 - insert.Slope++ 5-9, (b)(6), 02-012-45-5040 - bandeja tibial logic fit 5f/4t, (b)(6), 200-02-35 - rotula tres tetones 35mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a male patient, who had a right knee implanted, underwent a revision procedure approximately 5 years post the initial procedure.The patient presented with increasing knee pain, a sense of instability, and swelling.Plain radiographs revealed polyethylene wear, loosening of both the femoral and tibial components, and osteolysis affecting both bones.During the revision procedure, a femoral and tibial bone defect was identified consistent with aori type 2b.There was also a significant patellar defect and a notable soft-tissue reaction characterized by synovitis.The patient was revised to a competitor¿s devices.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.X-rays were provided.The explanted devices are not available for return.No further information.This is 1 of 4 reports.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: h6, h10, h11.No device was returned for evaluation; the reported event was confirmed by review of radiograph images provided.The most recent pre-revision radiographs showed that the space between the femoral and tibial component appears to decrease between the two provided a-p and sagittal view radiographs, which is a potential sign of insert wear.The femoral component also appears to be closer to the tibial tray near the medial side, which is similar to the wear pattern observed on the insert.In the sagittal view, there appears to be lucencies between the femoral component anterior flange and the femoral bone which indicates femoral loosening.A device image was also provided.There appears to be signs of wear and damage among both the medial and lateral articular surfaces.There are signs of wear and missing material on the posteriomedial aspect of the insert.There is also some observed pitting and signs of delamination and subsurface damage.The full extent of wear cannot be determined due to the presence of biological fluid staining across the explanted insert.No images were provided for the tibial tray, femoral component, or patellar implant.No manufacturing process-related non-conformances, deviations, or exceptions are associated with these devices.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 tibial insert prosthesis wear and femoral loosening.Possible causes for polyethylene wear include the confirmed femoral loosening, the alleged joint instability, alleged tibial loosening, high contact stresses during knee flexion, third body wear, patient-related conditions, inclusion of the polyethylene in the packaging recall with the insert being packaged for over five years prior to implantation, or any combination of these possibilities.Instability may be the result of increased soft-tissue laxity (looseness) or the confirmed femoral loosening and subsequent improper alignment and positioning of the prosthesis, but the presence of joint instability cannot be confirmed.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: OPTETRAK LOGIC
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22312189
• Report Number: 1038671-2025-02352
• Device Sequence Number: 8794230
• Product Code: JWH
• UDI-Device Identifier: 10885862158147
• UDI-Public: 10885862158147
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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 Catalogue Number: 02-010-03-0350
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG