MAUDE Adverse Event Report: EXACTECH, INC. NMC FEMORAL SZ 3; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	210-01-03
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	04/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was likely the result of wear of the tibial insert and suspected aseptic (non-infected) loosening.The cause and extent of the prosthesis wear cannot be determined because the revised components were not returned for evaluation and no x-rays or photographs were provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.D10: tray, tibia trapezoid cementedsize3f/3t, cat# 204-04-33, sn (b)(6).Insert, constrained condylar size3 9mm, cat# 208-23-09, sn (b)(6).Patella, three peg 35mm, cat# 200-02-35, sn (b)(6).Extension, femoral andtibialflutedstem 12mm od x11mm l, cat# 204-32-01, sn (b)(6).Component, femur non¿modular cck size 3, cat#210-01-03, sn (b)(6).
Event or Problem Description
It was reported that the patient underwent an initial right total knee arthroplasty.Subsequently, it was reported that the patient experienced pain, swelling, osteolysis and prosthesis wear.As a result, the patient underwent a right knee revision approximately 13 years after initial implantation.Patient was last known to be in stable condition.No further information available.

• Brand Name: NMC FEMORAL SZ 3
• 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: ashley harris ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24680613
• Report Number: 1038671-2026-00320
• Device Sequence Number: 15946624
• Product Code: JWH
• UDI-Device Identifier: 10885862057402
• UDI-Public: 10885862057402
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• 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): 03/24/2026

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: 06/15/2013
• Device Catalogue Number: 210-01-03
• 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: 09/23/2022
• Initial Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 06/17/2008
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male