MAUDE Adverse Event Report: EXACTECH, INC. NMC FEMORAL SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	210-01-04
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: optetrak three peg cemented patella (200-02-38, (b)(6)) optetrak tray tib cemtrap 4f/4t (204-04-44, (b)(6)) stem ext flut 12mm x 11 mm (204-32-01, (b)(6)) optetrak non-modular insert tib cc sz 4 (208-24-15, (b)(6)) non exactech- hv bone cement x2.Multiple mdr reports were filed for this event, please see associated report: 1038671-2022-01482.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.
Event or Problem Description
It was reported that approximately 87 months after a right total knee replacement procedure, the patient underwent a revision surgery to address prosthesis wear, effusion and instability.A revision operative report was provided.Post operative diagnosis noted instability and femoral component loosening.Intraoperatively the surgeon observed significant effusion and synovitis and delamination of the polyethylene component.It was noted there was no evidence of the polyethylene tibial component loosening.The surgeon observed the tibia was well fixed but there was debonding of the femoral component at the implant cement interface.No medical or surgical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The revision reported was likely due to prosthesis wear, instability, and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear, instability, and femoral debonding could not be determined as there were no details regarding cementing technique or environmental conditions provided, the devices were not returned for evaluation, and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NMC FEMORAL SZ 4
• 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: 21401871
• Report Number: 1038671-2025-01023
• Device Sequence Number: 9456003
• Product Code: JWH
• UDI-Device Identifier: 10885862057419
• UDI-Public: 10885862057419
• 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: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 09/29/2019
• Device Catalogue Number: 210-01-04
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/25/2025
• Date Device Manufactured: 10/02/2014
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male