MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 1, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	CC TIBIAL INSERT SZ 1, 9MM
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately 12 years 8 months after a left total knee replacement, the patient was revised due to instability overtime.The patient was revised to cc tibial insert sz 1 18mm.The event was not related to the breakage of a device.The event did not lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep unable to obtain images or x-rays.Product not returning due to hospital policy.
Additional Manufacturer Narrative
The reason for the reported revision due to instability cannot be conclusively determined; however, it may be due to soft tissue imbalance, patient anatomy, implant positioning, and/or implant selection.Subluxation and dislocation are known risks, as outlined in the ifu.H6: corrected component and investigation clinical codes.

• Brand Name: CC TIBIAL INSERT SZ 1, 9MM
• 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 ; gainesville 32653
• MDR Report Key: 19659309
• Report Number: 1038671-2024-02278
• Device Sequence Number: 15182001
• Product Code: JWH
• UDI-Device Identifier: 10885862054081
• UDI-Public: 10885862054081
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 11/18/2015
• Device Model Number: CC TIBIAL INSERT SZ 1, 9MM
• Device Catalogue Number: 208-21-09
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2010
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0019-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CEMENT RESTRICTOR SMALL.; FLEX OSTEOTOME-ROUND, NA.; NMC FEMORAL SZ 1D, 1.; STEM EXTENSION 40L X12MM.; THREE PEG PATELLA 35MM.; TIBIAL AUGMENT BLOCK 1/3-SZ 2 8MM.; TIBIAL STEM EXT. SCREW.; TRAPEZOID TIBIAL TRAY SZ 1F/2T, 2F/2T.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female