MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3.5, 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number	TRULIANT TIB IMP CRC INSERT SZ 3.5, 17MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	12/16/2021
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
As reported by the truliant knee clinical study; approximately fourteen days post initial tka, this (b)(6) female patient came to follow up appt with swollen knee.Fluid was drained.Patient was then transported to the emergency department for a syncopal event.Irrigation and debridement with poly exchange was performed a day after.Cultures were taken intra-operatively shown positive for infection.Patient started on 6 weeks antibiotics.Per clinical study this event is not related to the device but related to the procedure.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3, h6 and h9 have been updated accordingly.(h3) as reported by the truliant knee clinical study; approximately fourteen days post initial tka, this 61 y/o female patient came to follow up appt with swollen knee.Fluid was drained.Patient was then transported to the emergency department for a syncopal event.Irrigation and debridement with poly exchange was performed a day after.Cultures were taken intra-operatively shown positive for infection.Patient started on 6 weeks antibiotics.The event is not related to the device but related to the procedure.No additional information.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of surgical revision for infection 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 CRC INSERT SZ 3.5, 17MM
• 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: 13839717
• Report Number: 1038671-2022-00271
• Device Sequence Number: 991036
• Product Code: JWH
• UDI-Device Identifier: 10885862307736
• UDI-Public: 10885862307736
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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 Expiration Date: 10/18/2025
• Device Model Number: TRULIANT TIB IMP CRC INSERT SZ 3.5, 17MM
• Device Catalogue Number: 02-022-51-3517
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• 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-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5; - TRULIANT TIB FIT TRAY CEM SZ 3.5F
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: Black Or African American