MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 1D, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 1D, 15MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: three peg patella 29mm (cat# 200-02-29 / serial# (b)(6).Cemented trap tib tray sz 1df/1t (cat# 204-06-11 / serial# (b)(6).Stem extension 120l x10 mm (cat# 204-30-12 / serial# (b)(6).Stem extension 120l x12 mm (cat# 204-32-12 / serial# (b)(6).Cc femoral sz 1d, 1 (cat# 208-01-01 / serial# (b)(6).Cc distal fem augment sz 1, 5mm (cat# 208-05-01 / serial# (b)(6).Cc distal fem augment sz 1, 5mm (cat# 208-05-01 / serial# (b)(6).Cc stem ext adaptor 2 degree (cat# 208-09-02 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately ten years post initial tka, the patient had a polyethylene exchanged on an optetrak cc knee.Images and x-rays received.No patient information provided.
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.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: CC TIBIAL INSERT SZ 1D, 15MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: 18759907
• Report Number: 1038671-2024-00297
• Device Sequence Number: 15037352
• Product Code: JWH
• UDI-Device Identifier: 10885862054517
• UDI-Public: 10885862054517
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K011976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 07/29/2025

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: 02/06/2018
• Device Model Number: CC TIBIAL INSERT SZ 1D, 15MM
• Device Catalogue Number: 208-51-15
• 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: 01/27/2024
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown