MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 2, 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	CC TIBIAL INSERT SZ 2, 15MM
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Failure of Implant (1924)
Date of Event	04/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
During the week of april 17-25, representatives of exactech, inc.And exactech spain conducted an in person site visit with (b)(6) hospital.As a result of that site visit and at exactech's request, the hospital provided a retrospective excel listing of revision related to polyethylene wear that have been performed since 2010.These cases have not previously been reported to exactech as complaints.This patient (b)(6), was implanted with a 208-22-15-inserto tibial cc 2,15mm, serial number (b)(6), on (b)(6) 2017.The insert was manufactured on (b)(6) 2013, and was packaged in a vacuum bag with no evoh.The insert was manufactured on (b)(6) 2013, and was 3.7 years shelf age at the time of implant.Approximately six years post implantation, the patient underwent revision for wear of the polyethylene.No additional details are available at this time.
Additional Manufacturer Narrative
After further review of additional information received the following sections a2, a3, b5, g3, g6, h2, h3 and h6 have been updated accordingly.Section b5: additional information received indicates that this case does not have a polyethylene disease problem.Patient has chronic infection problem.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Section h10: (h3) 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; no device information was provided.The cause of the patient¿s infection and subsequent 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.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
Upon reassessment of the information received, it was determined that this event was reported in error.No serious injury or allegation(s) against the currently implanted device were reported.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: CC TIBIAL INSERT SZ 2, 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: 16971210
• Report Number: 1038671-2023-01072
• Device Sequence Number: 11375837
• Product Code: JWH
• UDI-Device Identifier: 10885862054197
• UDI-Public: 10885862054197
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/06/2025

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: 05/16/2018
• Device Model Number: CC TIBIAL INSERT SZ 2, 15MM
• Device Catalogue Number: 208-22-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 08/01/2023; Not provided; 08/06/2025
• Initial Report FDA Received Date: 05/21/2023
• Supplement Report FDA Received Date: 08/24/2023; 04/18/2024; 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2013
• 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 Age: 71 YR
• Patient Sex: Female