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

Catalog Number	200-02-35
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: 3766400 - 02-010-01-0340 - logic femoral ps cem right sz 4.3586776 - 02-012-44-4011 - logic tibia implant psc insert, sz 4, 11mm.3795289 - 02-012-45-4040 - lgc tibial fit tray cem sz 4f / 4t.3832369 - 200-02-35 - three peg patella 35mm.H3 - the revision reported may have been due to orientation of the femoral and tibial components, third body wear, instability, or any combination of these which led to wear of the tibial insert and patella component.However, this cannot be confirmed because the components were not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a 82 yo male patient, who had a right knee implanted, underwent a revision procedure approximately 8 years 10 months post the initial procedure.The patient was revised due to poly wear as well as flaking and delamination.The patient was revised to a 38mm patella, and the tibial insert was revised to a sz 4, 11mm.Fragments of polyethylene were present in the knee joint which the surgeon removed.X-rays were provided.There were no surgical delays during the procedure.The patient was last known to be in stable condition following the event.No explanted devices are available for analysis.The surgeon kept them.Device images were provided.No further information.

• 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: 21994060
• Report Number: 1038671-2025-02014
• Device Sequence Number: 12881837
• Product Code: JWH
• UDI-Device Identifier: 10885862039606
• UDI-Public: 10885862039606
• 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: 2015
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 05/09/2025

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: 01/14/2020
• Device Catalogue Number: 200-02-35
• 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: 02/11/2024
• Initial Report FDA Received Date: 05/09/2025
• Date Device Manufactured: 01/17/2015
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 90 KG