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 Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2024-01534, 1038671-2025-00545, 1038671-2025-00542 d10: 2533330 200-02-35 - three peg patella 35mm.2471571 204-04-33 - trapezoid tibial tray sz 3f/3t.2450618 204-32-01 - fluted stem extension 11l x 12 mm.1566999 208-23-15 - cc tibial insert sz 3, 15mm.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-01534, 1038671-2025-00545, 1038671-2025-00542.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 116 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening, bone fracture, implant pain, joint laxity, osteolysis, swelling/edema, and synovitis.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21276841
• Report Number: 1038671-2025-00573
• Device Sequence Number: 8495645
• Product Code: JWH
• UDI-Device Identifier: 10885862057402
• UDI-Public: 10885862057402
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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: 10/11/2017
• 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: 10/10/2023
• Initial Report FDA Received Date: 01/30/2025
• Date Device Manufactured: 10/10/2012
• 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; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male