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

Catalog Number	02-012-44-2015
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 73 yo female patient, initial right knee implanted in (b)(6) 2018, underwent a revision procedure in (b)(6) 2025, approximately 6 years 9 months post the initial procedure.The surgeon performed a synovectomy surrounding the affected knee and found severe osteolysis present.The patella exhibited medial to lateral wear along the tracking path.The tibial insert had mild medial wear.Additional wear on the posterior post found.The femoral and tibial components were well fixed.The patella and psc insert were replaced with same size/type component.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The explanted devices are not available for return.They are being retained by the hospital for analysis.Device images were provided.No further information.This is 1 of 2 reports for this event.
Additional Manufacturer Narrative
D10: concomitants: 02-010-01-0320 - lgc femoral ps cem right sz 2: (b)(6), 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t: (b)(6), 204-34-02 - fluted stem extension 25l x 14 mm: (b)(6), 204-70-00 - tibial stem ext.Screw: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: h3 - the revision reported was likely the result of prosthesis wear of the tibial insert and patella secondary to potential contributions from instability that resulted in higher medial in-vivo loading and component rotational imbalance and/or flexion instability.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs were not provided.H6 - investigation type, findings, conclusion.The following sections were corrected: h6 - investigation codes 4118, 3233, 11 no longer applies.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: 21877160
• Report Number: 1038671-2025-01864
• Device Sequence Number: 18093612
• Product Code: JWH
• UDI-Device Identifier: 10885862173508
• UDI-Public: 10885862173508
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/28/2025

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: 05/14/2022
• Device Catalogue Number: 02-012-44-2015
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2014
• 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 Age: 73 YR
• Patient Sex: Female