MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ3, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-23-09
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right knee was revised approximately 12 years post op.Patient was revised due to wear and pain.A new vit e 9mm insert placed with no issues.Explants not available.
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): (b)(6), 200-02-35 - three peg patella 35mm.(b)(6), 204-04-33 - trapezoid tibial tray sz 3f/3t.(b)(6), 204-34-02 - fluted stem extension 25l x 14 mm.(b)(6), 204-70-00 - tibial stem ext.Screw.(b)(6), 230-03-03 - optetrak asy,cr cemented femoral, sz 3, (b)(6), 620-00-02 - platelet rich plasma kit with spray tips.(b)(6), 620-11-02 - accelerate conc.Sys rep by 620-12-02.
Additional Manufacturer Narrative
The revision reported was likely the result of tibial insert prosthesis wear over 12 years of implantation.Possible causes for polyethylene wear include high contract stresses during knee flexion, implant malalignment, patient-related conditions, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.As the suspect device was not provided, none of these potential causes or their contribution to the sequence of events can be confirmed.H6: corrected medical device, component, and investigation clinical codes.

• Brand Name: CR TIBIAL INSERT SZ3, 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20233585
• Report Number: 1038671-2024-03552
• Device Sequence Number: 20873684
• Product Code: JWH
• UDI-Device Identifier: 10885862040244
• UDI-Public: 10885862040244
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 07/15/2025

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: 12/07/2017
• Device Catalogue Number: 200-23-09
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 07/15/2025
• Date Device Manufactured: 12/08/2009
• 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: Unknown