MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 15MM; SEE H10

Model Number	CC TIBIAL INSERT SZ 3, 15MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient, initial right knee implanted on (b)(6) 2013, underwent a revision procedure on (b)(6) 2024, approximately 10 years 2 months post the initial procedure.The 15mm cc poly was exchanged for an 18mm poly.There were no surgical delays or device breakages during the procedure.No x-rays were able to be obtained.The patient was last known to be in stable condition following the event.No device returns for analysis available as it is against the hospital policy.No device images were available.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
The reason for the reported revision cannot be confirmed from the information provided but may be due to inclusion of the polyethylene in the packaging recall, wear, loosening, infection, fracture, instability, and/or patient related factors.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information, images, or radiographs were not provided.D1: corrected.D4: corrected.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: CC TIBIAL INSERT SZ 3, 15MM
• Common Device Name: SEE H10
• 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 66 court; gainesville, FL 32653 ; 3523164164
• MDR Report Key: 18803747
• Report Number: 1038671-2024-00337
• Device Sequence Number: 20656793
• Product Code: JWH
• UDI-Device Identifier: 10885862054272
• UDI-Public: 10885862054272
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2015
• Device Model Number: CC TIBIAL INSERT SZ 3, 15MM
• Device Catalogue Number: 208-23-15
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 07/16/2025
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown