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

Catalog Number	200-02-29
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Synovitis (2094); Osteolysis (2377)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-010-01-0325 - lgc femoral ps cem right sz 2.5, (b)(6), 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 5t, (b)(6), 204-70-00 - tibial stem ext.Screw, (b)(6), 204-34-02 - fluted stem extension 25l x 14 mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that an 81 yo female patient, who had a right knee implanted, underwent a revision procedure approximately 5 years 2 months post the initial procedure.The surgeon performed a synovectomy surrounding the affected knee.Mild osteolysis was found present.The patella exhibited medial to lateral wear along tracking path.The tibial insert had mild medial wear.Additional wear on the posterior post noted.The femoral and tibial components were well fixed.The patella and liner were exchanged.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 provided.The explanted devices are not available for return as they were discarded.There was no device images provided.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear or due to 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 and images, radiographs, and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• 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, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 22671664
• Report Number: 1038671-2025-02645
• Device Sequence Number: 7626503
• Product Code: JWH
• UDI-Device Identifier: 10885862039583
• UDI-Public: 10885862039583
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932690
• 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): 08/26/2025

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: 05/23/2021
• Device Catalogue Number: 200-02-29
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2016
• 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: 81 YR
• Patient Sex: Female