MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2.5 9MM; SEE H10

Model Number	02-022-35-2509
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitant medical products: serial #: (b)(4), category #: 521-78-32 threaded pin size 3.0 collarless 2pk, serial #: (b)(4), category #: 02-022-45-2525 truliant tib fit tray cem sz 2.5f / 2.5t, serial #: (b)(4), category #: 200-07-29 advanced patella 29m 3 peg implant, serial #: (b)(4), category #: 02-020-11-0225 truliant ps cem fem ps cem left sz 2.5, 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 planned revision cannot be conclusively determined; however, it is most likely related to the physician statement that removal of the implant is indicated to relieve the patient¿s pain.The patient has a reported history of osteoarthritis, rheumatoid arthritis, and fibromyalgia, all of these diseases cause joint and general body pain.These diseases may also be a contributor to the patient falls as they are related to degeneration in all joints, such as feet and ankles [osteoarthritis and rheumatoid arthritis] or limb numbness [fibromyalgia].These devices are used for treatment not diagnosis.
Event or Problem Description
It was reported from legal that on (b)(6) 2019, the patient underwent a total left knee replacement and was implanted with a truliant device.This patient has bilateral tka.In (b)(6) 2021, the patient was descending a set of stairs when her knees gave out.She fell down the stairs and fractured her right ankle.This injury resulted in significant pain and required extensive rehabilitation.Several months later, the patient suffered another fall due to weakness in her knees.This fall resulted in a left foot fracture.On (b)(6) 2019, the patient reported that the pain, weakness, and popping in her knees had become increasingly worse over the past year.The patient¿s physician stated that ¿a revision of the implant is indicated to relieve the patient¿s pain¿.The patient agreed to undergo a left total knee replacement revision surgery to remove the truliant device from her left knee, information provided does not have a date for this future surgery.There is no other patient demographic or medical history available.There is no information on the surgical procedure or patient outcome.There is no device return.There are no photos or other images of the device provided.No additional information is available.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 16626385
• Report Number: 1038671-2023-00518
• Device Sequence Number: 5310819
• Product Code: JWH
• UDI-Device Identifier: 10885862304162
• UDI-Public: 10885862304162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

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: 06/25/2026
• Device Model Number: 02-022-35-2509
• Device Catalogue Number: 02-022-35-2509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/28/2023
• Date Device Manufactured: 07/02/2018
• 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: Disability
• Patient Sex: Female