MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	02-022-45-2525
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10.Concomitants: (b)(6)- 02-022-35-2509 - truliant tib imp ps insert sz 2.5 9mm.(b)(6)- 02-012-60-1425 - logic stem ext 14mm x 25mm.(b)(6)- 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t.(b)(6)- 02-020-11-0325 - truliant ps cem fem ps cem right sz 2.5.(b)(6)- 200-07-29 - advanced patella 29m 3 peg implant.
Event or Problem Description
It was reported via a legal notification, that a patient, underwent an initial right total knee replacement surgery on (b)(6) 2020 due to osteoarthritis.The patient underwent revision surgery of her right knee (b)(6) 2021, approximately 1 year 9 months post initial procedure.Complications -there was a stem tibial component in place.On extraction of the tibial component there was fracture of the proximal medial tibia.This did not extend distally.There is no violation of the medial retinaculum or medial collateral ligament.The tibial extractor was applied and on backslapping the tibial component, there was noted to be removal of the tibial tray however the medial proximal tibia remained attached to the trachea and there was fracture.The proximal lateral tibia with the tibial tubercle remained intact.There is no extension of the fracture distally.It did not require any fracture fixation but instead use of a press-fit tibial sleeve with a long press-fit tibial stem was planned.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
H10.Additional information- g2, h6 health effect - impact code & medical device problem code.H3.Investigation results-there is no reported device malfunction in the operative report.The bone fracture is most likely due to procedure or patient conditions such as osteoporosis or osteopenia or other condition related to morbid obesity; however, it is not known with the information provided.Preoperative x-rays showed no abnormalities.The fracture did not require fixation.In the ifu states that unintended bone fractures are a device specific risk.; and that as part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.These devices are used for treatment not diagnosis.There is no additional information available.

• Brand Name: TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523782617
• MDR Report Key: 17710179
• Report Number: 1038671-2023-02193
• Device Sequence Number: 6731051
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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 Catalogue Number: 02-022-45-2525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 05/31/2024; 09/09/2026
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 05/31/2024; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• 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; Other
• Patient Age: 55 YR
• Patient Sex: Female