MAUDE Adverse Event Report: EXACTECH, INC. NMC FEMORAL SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	210-01-02
Medical Device Problem Codes	Mechanical Problem (1384); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Bone Fracture(s) (1870); Failure of Implant (1924); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Ankylosis (4527); Metal Related Pathology (4530); Implant Pain (4561); Joint effusion (4849)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: (b)(6) 203-96-02 - (11-2324) saw blade new stryk (.035); (b)(6) 203-96-01 - (11-2222) saw blade new stryk (.050); (b)(6) 203-96-03 - (11-2216) saw blade new stryker (.050); (b)(6) 204-34-04 - fluted stem extension 40l x 14 mm; (b)(6) 204-04-21 - trapezoid tibial tray sz 1f/1t, 2f/1t; (b)(6) 200-02-29 - three peg patella 29mm; (b)(6) 210-01-02 - nmc femoral sz 2.The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported via legal documentation that approximately 129 months after a left total knee replacement procedure, the patient underwent a revision procedure to address prosthesis wear, failure of left knee total knee arthroplasty prosthesis with loose components; cortical fracture of left femur; severe osteolysis, loss of range of motion; chronic pain; injuries to tissue and cone of the left knee; subchondral cyst; joint effusion; metallosis.No further issues or complications were reported.No additional information is available.
Additional Manufacturer Narrative
The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear, femoral bone fracture, disassembly, loss of range of motion, patellar loosening, and femoral loosening or due to inclusion of the polyethylene in the packaging recall.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.H6: corrected health effect, medical device, and investigation clinical codes.

• Brand Name: NMC FEMORAL SZ 2
• 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 ; 3523771140
• MDR Report Key: 20688801
• Report Number: 1038671-2024-04395
• Device Sequence Number: 7230080
• Product Code: JWH
• UDI-Device Identifier: 10885862057396
• UDI-Public: 10885862057396
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 01/23/2025

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: 06/15/2013
• Device Catalogue Number: 210-01-02
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/23/2025
• Date Device Manufactured: 06/17/2008
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female