MAUDE Adverse Event Report: EXACTECH, INC. CR TIBIAL INSERT SZ4, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	200-24-09
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, the patient had an initial left tka on (b)(6) 1995.The patient complained of joint pain and was revised on (b)(6) 2023.The patient was revised to truliant crc tib insert sz 4, 17mm, 02-022-51-4017.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.No other patient information/medical history reported.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
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 pain 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 bilateral knee replacements.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, d6a, h4, h6.Mdr section codes updated/corrected: b, c, d, g.The reason for the clinical symptom of pain reported cannot be conclusively determined and the event cannot be confirmed because the devices were not available for evaluation, and relevant patient information, images, or radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: CR TIBIAL INSERT SZ4, 9MM
• 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: 16758737
• Report Number: 1038671-2023-00715
• Device Sequence Number: 14218968
• Product Code: JWH
• UDI-Device Identifier: 10885862040299
• UDI-Public: 10885862040299
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/22/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2012
• Device Model Number: 200-24-09
• Device Catalogue Number: 200-24-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 08/02/2024; 07/21/2025
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 01/10/2024; 08/12/2024; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2007
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female