MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 5, 18MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Catalog Number	208-25-18
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the 73 year old male patient had 2 prior right knee revisions on (b)(6) 2010 and 3/17/2021.The patient presented to his surgeon with pain and a history of a right total knee arthroplasty revision using exactech recalled polyethylene.The patient was revised on (b)(6) 2023.The synovial fluid in the joint was clear without evidence of purulence.A complete synovectomy was performed removing scar tissue and re-establishing the anterior compartment of the knee, suprapatellar pouch and medial and lateral gutters.Examination of the implants revealed that the femoral component was well fixed and appropriately sized.The tibial component was well fixed, aligned and oriented.The patellar component was well fixed.The polyethylene liner was removed and noted to have no significant wear.The patient emerged from anesthesia and was transferred to the pacu in stable condition.
Additional Manufacturer Narrative
Pending investigation.Serial #: (b)(4) category #: 204-04-54 - trapezoid tibial tray sz 5f/4t, serial #: (b)(4) category #: 204-44-08 - tibial augment block 1/3-sz 4 8mm, serial #: (b)(4) category #: 02-012-60-1616 - logic stem ext 16mm x 160mm.
Event or Problem Description
Additional information-preoperatively the patient had flexion contracture and lack of full flexion.Hospital care time: admitted (b)(6) 2023 and discharged (b)(6) 2023.Patient was revised to an exactech optetrak insert.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Serial #: (b)(6), insert tib 5x18mm knee cndyl cnstrn screw optetrak.The serial number (b)(6), does not exist for an insert as reported in the revision operative report of (b)(6) 2021 for devices that were implanted.H3.Investigation results device information was not provided.The cause of the patient¿s problems with range of motion and subsequent polyethylene revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The patient has had previous knee revisions.These devices are used for treatment not diagnosis.There is no other information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, d1, d4, g4, h4, h6: clinical code, device problem code, component code, type of investigation codes.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CC TIBIAL INSERT SZ 5, 18MM
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16533928
• Report Number: 1038671-2023-00427
• Device Sequence Number: 14975795
• Product Code: JWH
• UDI-Device Identifier: 10885862054449
• UDI-Public: 10885862054449
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/28/2025

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: 04/20/2025
• Device Catalogue Number: 208-25-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 08/23/2023; 10/28/2025
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 08/23/2023; 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male