MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CR STD, SIZE 3, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CR STD, SIZE 3, 10MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech knee replacement study, approximately one year post initial tka, the (b)(6) male patient complains of discomfort and some loss of motion.The event is still ongoing.Per clinical study case report form indicates this event is unlikely related to devices and possibly related to procedure.
Additional Manufacturer Narrative
Concomitant medical products: truliant cr cem fem cr cem left sz 3 (cat# 02-020-13-0230); truliant tib fit tray cem sz 3f / 3t (cat# 02-022-45-3030); advanced patella 35mm 3 peg implant (cat# 200-07-35).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as reported by the exactech knee replacement study, approximately one year post initial tka for osteoarthritis, the 58 y/o obese female patient complains of discomfort and some loss of motion due to arthrofibrosis.Action taken: patient is scheduled for pre-op visit.The event is still ongoing.Per clinical study case report form indicates this event is unlikely related to devices and possibly related to procedure.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 subsequent knee discomfort/pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.These devices are used for treatment not diagnosis.

• Brand Name: TRULIANT TIB IMP CR STD, SIZE 3, 10MM
• 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: 14515416
• Report Number: 1038671-2022-00610
• Device Sequence Number: 14860128
• Product Code: JWH
• UDI-Device Identifier: 10885862311368
• UDI-Public: 10885862311368
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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 Model Number: TRULIANT TIB IMP CR STD, SIZE 3, 10MM
• Device Catalogue Number: 02-022-47-3010
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 09/15/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Race: White