MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB FIT TRAY CEM SZ 5F / 4T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRULIANT TIB FIT TRAY CEM SZ 5F / 4T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.Concomitant medical products: tru fluted stm ext 12mm x 160mm blast (cat# 02-012-64-1216 / serial# (b)(4)).
Event or Problem Description
As reported, during the implantation of the left tibial component the male patient sustained a tibial fracture.Surgeon thinks that the placement of the tibial gps tracker pins placed caused a weakness in the bone which subsequently fractured during tibial implantation.Surgeon added a tibial stem and smith and nephew plates/screws to secure the site and a successful implantation of the tibial tray.The device is not available for evaluation as the device remains implanted.It was reported that it appears there was no patient impact due to a delay to repair the fracture.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
(h3) as reported, during the implantation of the left tibial component the male patient sustained a tibial fracture.The surgeon believes that the placement of the tibial gps tracker pins may have caused a weakness in the bone which potentially contributed to the fracture during tibial implantation.The surgeon added a tibial stem and smith and nephew plates/screws to fix the fracture site and the tibial try was successfully implanted.The pins and tracker are not available for analysis as the hospital will sterilize and re-use the equipment.The patient remained stable throughout the surgery and was last known to be in stable condition following the event.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.Fracture is a known potential complication associated with the use of these devices.The cause of the reported tibial fracture is most likely related to traumatic forces encountered during the preparation of the bone for use of the gps system.

• Brand Name: TRULIANT TIB FIT TRAY CEM SZ 5F / 4T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11359351
• Report Number: 1038671-2021-00062
• Device Sequence Number: 19480465
• Product Code: JWH
• UDI-Device Identifier: 10885862305930
• UDI-Public: 10885862305930
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2021

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 FIT TRAY CEM SZ 5F / 4T
• Device Catalogue Number: 02-022-45-5040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability