MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 3, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 3, 15MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, approximately eleven years post initial left side tka of a 74 y/o male patient, the surgeon performed a wash out of the infected knee and replaced the poly as part of the washout.The patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.The device is not available for evaluation due to device was disposed by the hospital.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely patient-related conditions.These devices are used for treatment not diagnosis.
Event or Problem Description
As reported, approximately eleven years post initial left side tka of a 74 y/o male patient, the surgeon performed a wash out of the infected knee and replaced the poly as part of the washout.The patient was revised to exactech devices.There was no breakage of device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.The device is not available for evaluation due to device was disposed by the hospital.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d8, h6 health effect - clinical code, component code, type of investigation, investigation conclusion and h11.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: CC TIBIAL INSERT SZ 3, 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15754719
• Report Number: 1038671-2022-01425
• Device Sequence Number: 2918582
• Product Code: JWH
• UDI-Device Identifier: 10885862054272
• UDI-Public: 10885862054272
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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 Model Number: CC TIBIAL INSERT SZ 3, 15MM
• Device Catalogue Number: 208-23-15
• 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: 10/20/2022
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: FLUTED STEM EXTENTION.; OPTETRAK FEMORAL AUG BLOCK & SCREW.; OPTETRAK FEMORAL COMPONENT.; STEM EXTENSION 80 X 16 MM.; TRAPEZOID TIBIAL TRAY SZ 3F/3T.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male