MAUDE Adverse Event Report: Exactech, Inc. CEMENTED FINNED TIB. TRAY SZ 1DF/2T; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Catalog Number	200-06-12
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a knee replacement utilizing an optetrak cr slope++ tibial insert.Subsequently, the patient experienced knee pain and swelling.The surgeon diagnosed wear of the tibial insert, and a revision procedure was performed.During the revision, damage and wear were observed on the retrieved tibial insert and tibial tray.As a result, the tibial insert, tibial tray, and femoral component were explanted and replaced with an activit-e psc size 1, 15 mm insert, a size 1f/1t tibial tray, and a logic femoral component size 1 right.Additional implants utilized during the procedure included a 14 mm × 80 mm stem extension, two size 1t 5 mm tibial augments, a size 1 5 mm posterior femoral augment, a size 1 10 mm femoral augment, and a size 1 5 mm distal femoral augment.The patient outcome was not further reported.

• Brand Name: CEMENTED FINNED TIB. TRAY SZ 1DF/2T
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; +1(352)377-1140
• MDR Report Key: 50881081
• Report Number: 1038671-2026-01226
• Device Sequence Number: 10708278
• Product Code: JWH
• UDI-Device Identifier: 10885862039903
• UDI-Public: 10885862039903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 08/19/2018
• Device Catalogue Number: 200-06-12
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 08/27/2013
• 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: Hospitalization
• Patient Sex: Unknown