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	Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right total knee arthroplasty.Subsequently, it was reported that the patient experienced pain, swelling, stiffness, loss of motion, weakness and difficulty ambulating.As a result, the patient underwent a right knee revision approximately 13 years and 7 months after initial implantation.Provided operative notes report tibial loosening and wear of the tibial insert.It was later reported that the femoral component was found to be debonded.The patient was last reported to be stable.No further patient impact reported.No further information available.
Additional Manufacturer Narrative
D10: 208-24-09 - cc tibial insert sz 4, 9mm: (b)(6).210-01-04 - nmc femoral sz 4: (b)(6).208-04-43 - trap tray, offset alpha cem., sz 4f/4t: (b)(6).208-04-72 - screw, offset, sz dd.204-44-89 - tibial augment block 1/3-sz 4 11mm llrm: (b)(6).204-64-08 - tibial augment block 1/2-sz 4 8mm.200-02-35 - three peg patella 35mm.204-32-01 - fluted stem extension 11l x 12 mm.204-34-12 - fluted stem extension 120l x 14 mm: (b)(6).204-38-12 - stem extension w/slot 120l x18 mm: (b)(6).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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were added/corrected: h6: clinical code, medical device problem code, component code, type of investigation, investigation findings, investigation conclusion.The reason for the revision reported cannot be confirmed from the information provided but may be the result of tibial loosening, loss of range of motion, prosthesis wear, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.Based on the reported information, it appears that the pain, swelling, osteolysis, synovitis, ambulation difficulties, osteolysis, and synovitis may be related to the reported loosening and wear.Additionally, these devices appear to have been implanted for over ten years prior to the reported event.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 23575362
• Report Number: 1038671-2025-03344
• Device Sequence Number: 9223164
• 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: 2009
• Device Explanted Year: 2023
• 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): 02/10/2026

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: 06/29/2014
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• 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: 49 YR
• Patient Sex: Male