MAUDE Adverse Event Report: EXACTECH, INC. INSET PATELLA 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-05-26
Medical Device Problem Codes	Naturally Worn (2988); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)
Date of Event	02/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 204-34-04 - fluted stem extension 40l x 14 mm: (b)(6), 204-64-88 - tibial augment block 1/2-sz 4 11mm rllm: (b)(6), 208-04-44 - trap tray, offset beta cem., sz 4f/4t: (b)(6), 234-02-04 - optetrak asy,ps cemented femoral, sz 4: (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported a 69 yo male patient, who had a left tka, underwent a revision procedure, approximately 16 years 4 months post the initial procedure.The patient presented to the surgeon¿s office with complaints of stiffness from swelling, pain, and dissatisfaction with their left total knee.Decreased motion was present.The patient was scheduled for a revision of left tka possible polyethylene swap vs.Femoral component revision.The patient had revision surgery and underwent a tibial poly implant swap and patella implant swap.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-ray images were provided.The explanted devices are not available for return.They were discarded by the hospital.Device images were provided.No further information.This is 1 of 2 reports for this event.

• Brand Name: INSET PATELLA 26MM
• 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: 24492072
• Report Number: 1038671-2026-00214
• Device Sequence Number: 10681931
• Product Code: JWH
• UDI-Device Identifier: 10885862039842
• UDI-Public: 10885862039842
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 03/02/2026

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: 12/04/2012
• Device Catalogue Number: 200-05-26
• 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: 02/16/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2007
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 102 KG