MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT CR CEM FEM CR CEM LEFT SZ 4.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT CR CEM FEM CR CEM LEFT SZ 4.5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: truliant tib imp crc insert sz 4.5, 11m (cat# 02-022-51-4511) and truliant tib fit tray cem sz 4.5f/4.5t (cat# 02-022-45-4545).Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported by the exactech truliant knee clinical study, approximately three months post initial rtka, this (b)(6) female patient's knee was still stiff.Surgeon did closed manipulation nineteen days later and patient will follow up with physical therapy.Per clinical study this event is not related to the device but definitely related to the procedure.
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 truliant knee clinical study, approximately three months post initial rtka for osteoarthritis, this 62 y/o obese female patient's knee was still stiff.Surgeon did closed manipulation nineteen days later and patient will follow up with physical therapy.Per clinical study this event is not related to the device but definitely related to the 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 pain and stiffness 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 CR CEM FEM CR CEM LEFT SZ 4.5
• 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: 14027558
• Report Number: 1038671-2022-00381
• Device Sequence Number: 17656581
• Product Code: JWH
• UDI-Device Identifier: 10885862320650
• UDI-Public: 10885862320650
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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 CR CEM FEM CR CEM LEFT SZ 4.5
• Device Catalogue Number: 02-020-13-0245
• 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: 03/17/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 09/20/2022
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Race: Black Or African American