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

Catalog Number	02-012-49-1011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Osteolysis (2377); Metal Related Pathology (4530)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 21-0901-19y-v1 - stryker lpi s7/6/5/4 h.Sierra 90*13/21*1,19.(b)(6), 02-010-04-0210 - logic femur cr poroso nº1 izq.(b)(6), 02-012-45-1020 - bandeja tibial logic fit 1f/2t.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 77 yo female patient, who had a left knee implanted, underwent a revision procedure approximately 6 years 9 months post the initial procedure.The patient was revised due to premature polyethylene wear with massive osteolysis.They were 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.
Event or Problem Description
Although it was not alleged by the reporter, investigation noted evidence of metal component wear based on analysis of photographic evidence depicting possible tibial tray wear/damage and possible tissue discoloration as well as analysis of radiographic evidence that indicates metal debris in the joint.This is 1 of 3 reports.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b5.H3 - the revision reported was likely the result of tibial insert prosthesis wear, which ultimately led to metal-on-metal wear of the femoral and tibial tray components.Possible causes for polyethylene wear include high contact stresses during knee flexion, excessive posterior slope, and inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation.H6 - clincal code added, and investigation coding updated.H10 - mdr reference numbers added.The following sections were corrected: h6 - codes 4118, 3233, and 11 no longer apply.

• 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: 22319271
• Report Number: 1038671-2025-02361
• Device Sequence Number: 9024071
• Product Code: JWH
• UDI-Device Identifier: 10885862174215
• UDI-Public: 10885862174215
• 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: 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): 07/03/2025

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: 07/31/2021
• Device Catalogue Number: 02-012-49-1011
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2013
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female