MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ 5, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	200-25-11
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a right knee revision procedure approximately some unknown months after a total knee replacement surgery.The patient experienced pain and osteolysis.The surgeon reported the knee insert was broken and all components were removed and replaced with a different (unknown) construct.No surgical or medical interventions were reported.The patient was last known to be in stable condition.No additional information is available.
Additional Manufacturer Narrative
D10: (b)(6) 200-02-38 - three peg patella 38mm (b)(6) 200-25-11 - cr tibial insert sz 5, 11mm (b)(6) 201-46-10 - holding pin headless 3" (4 pk) (b)(6) 204-04-55 - trapezoid tibial tray sz 5f/5t (b)(6) 204-34-02 - fluted stem extension 25l x 14 mm (b)(6) 204-70-00 - tibial stem ext.Screw (b)(6) 230-03-05 - optetrak asy,cr cemented femoral, sz 5, (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.The product associated with the reported event is within the scope of recall z-0019-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
The revision reported was likely the result of prosthesis wear over the course of 10 years, which led to fracture of the posterior medial aspect.Possible causes for polyethylene wear include high contact stress during knee flexion and extension, patient-related factors, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.H6: corrected investigation clinical codes.

• Brand Name: CR TIBIAL INSERT SZ 5, 11MM
• 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
• MDR Report Key: 22184868
• Report Number: 1038671-2025-02276
• Device Sequence Number: 8799332
• Product Code: JWH
• UDI-Device Identifier: 10885862040350
• UDI-Public: 10885862040350
• 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: 2011
• Device Explanted Year: 2025
• 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): 08/08/2025

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: 06/17/2017
• Device Catalogue Number: 200-25-11
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 06/18/2009
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown