MAUDE Adverse Event Report: EXACTECH, INC. TRU CC TIB INSERT SIZE 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-2015
Medical Device Problem Codes	Mechanical Problem (1384); Lack of Effect (4065)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 6641890, 02-010-06-0320 - tru cc femoral size 2 right.6931290, 02-012-45-2010 - lgc tibial fit tray cem sz 2f/1t.A323354, 02-012-60-1280 - tru stem ext 12mm x 80mm.A207994, 02-012-60-1680 - tru stem ext 16mm x 80mm.6165557, 208-05-02 - cc distal fem augment sz 2, 5mm.6314557, 400-40-14 - flex osteotome-flat, nar.A108900, 400-40-14 - flex osteotome-flat, nar.
Event or Problem Description
As reported, approximately one year ago the patient was revised from competitor devices to a cck.Recently, the patient came in stiff, so was downsized from a 15 cck insert to a 9 cck insert.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reported revision due to stiffness cannot be conclusively determined; however, it may be due to patient factors/etiology, component positioning, arthrofibrosis, infection and/or implant selection.This cannot be confirmed because the devices were not available for evaluation, and relevant patient information, 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: TRU CC TIB INSERT SIZE 2, 15MM
• 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: 20086018
• Report Number: 1038671-2024-03134
• Device Sequence Number: 7580800
• Product Code: JWH
• UDI-Device Identifier: 10885862265890
• UDI-Public: 10885862265890
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: 09/24/2026
• Device Catalogue Number: 02-012-65-2015
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2018
• 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
• Patient Sex: Female