MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 3, 13MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	06/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d10: concomitant products: - holding pin headless 3" (4 pk) (cat# 201-46-10 / serial# (b)(6); - trapezoid tibial tray sz 3f/2t (cat# 204-04-32 / serial# (b)(6); - fluted stem extension 40l x 14 mm (cat# 204-34-04 / serial# (b)(6); - fluted stem extension 40l x 14 mm (cat# 204-34-04 / serial# (b)(6); - cc femoral sz 3 (cat# 208-01-03 / serial# (b)(6); - cc distal fem augment sz 3, 5mm (cat# 208-05-03 / serial# (b)(6); - cc distal fem augment sz 3, 5mm (cat# 208-05-03 / serial# (b)(6); - cc stem ext adaptor 5 degree (cat# 208-09-05 / serial# (b)(6); - platelet rich plasma kit with spray tips (cat# 620-00-02 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, approximately eleven years post initial tka, patient was revised due to pain and bad osteolysis.There was no issues removing components.Competitor's revision knee was implanted.The explants are not available for evaluation.No further information.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear.Additional reasons for the reported revision may be 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 radiographs and relevant clinical information were not provided.H6: corrected health effect, medical device, component, and investigation clinical codes.

• Brand Name: CC TIBIAL INSERT SZ 3, 13MM
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17201743
• Report Number: 1038671-2023-01461
• Device Sequence Number: 20518648
• Product Code: JWH
• UDI-Device Identifier: 10885862054265
• UDI-Public: 10885862054265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• 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): 02/20/2025

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: 01/01/2017
• Device Model Number: CC TIBIAL INSERT SZ 3, 13MM
• Device Catalogue Number: 208-23-13
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2012
• 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: Female