MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal

Model Number	TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
Medical Device Problem Codes	Naturally Worn (2988); Patient Device Interaction Problem (4001); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561); Swelling/ Edema (4577); Arthrofibrosis (4885)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitants; 5698527, 02-012-60-1425 - logic stem ext 14mm x 25mm.5700482, 02-022-45-2525 - truliant tib fit tray cem sz 2.5f / 2.5t.6293157, 204-70-00 - tibial stem ext.Screw.6306257, 02-020-11-0325 - truliant ps cem fem ps cem right sz 2.5.6406012, 200-07-29 - advanced patella 29m 3 peg implant.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via legal notification, that patient, underwent initial right total knee replacement surgery on (b)(6) 2020 and was implanted with a truliant device, including a truliant posterior stabilized insert, size 2.5, 9mm made of polyethylene.Plaintiff underwent revision surgery of her right knee (b)(6) 2021, approximately 1 year 9 months post initial procedure.Upon information and belief, the need for revision in plaintiff's right knee was due to premature polyethylene wear of the tibial insert.Following the revision surgery, plaintiff continues to be limited in her activities of daily living.Despite undergoing revision surgery, plaintiff experiences daily pain and discomfort in her right knee which limits her activities of daily living and impacts her quality of life.No device return anticipated due to this being a legal case.No further information.
Additional Manufacturer Narrative
H6.The revision reported in (b)(4) may have been the result of prosthesis wear as stated in the legal documentation.However, this cannot be confirmed as the devices were not available for evaluation and images/pre-revision radiographs were not provided.A contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.
Event or Problem Description
Additional information- as reported via legal documentation, a patient underwent an initial right total knee replacement surgery on (b)(6) 2020 and was implanted with a truliant device, the patient underwent revision surgery of her right knee (b)(6) 2021, approximately 1 year 9 months post initial procedure.The patient was revised to a competitor¿s devices.Revision operative report of (b)(6) 2021.Post operative diagnosis- severe arthrofibrosis following right total knee arthroplasty.Indication for surgery- she has had ongoing knee pain and knee flexion contracture initially with range of motion only from 40 to 90 degrees.She was subsequently referred to for progressively worsening knee stiffness and pain.Work-up for infection was negative.On initial evaluation her range of motion was only 68 degrees of knee flexion contracture and flexion to 85 degrees.There were no apparent radiographic anomalies with the x-rays.Findings - 65-degree knee flexion contracture and only flexed to 95 degrees preoperatively.Postoperatively range of motion was to 125 degrees.Upon entry into the knee joint there is extensive hypertrophic scarring.There was bridging fibrotic tissue from the intercondylar notch to the patellar tendon with heterotopic bone.This was impeding knee extension.The surgeon noted that there was not any polyethylene wear, and there was not any gross loosening of the femoral component.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.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
H6.Additional investigation results -the truliant tib imp device with serial number (b)(6) is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient¿s arthrofibrosis and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy "[bmi 46 morbidly obese]", or other condition that impacts the performance of the device.These devices are used for treatment not diagnosis.There is no other information available.

• Brand Name: TRULIANT
• Common Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal
• 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 ; 3523771140
• MDR Report Key: 16378411
• Report Number: 1038671-2023-00170
• Device Sequence Number: 6082205
• Product Code: JWH
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 2.5 9MM
• Device Catalogue Number: 02-022-35-2509
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 07/26/2023; 09/21/2026
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 04/17/2023; 07/26/2023; 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2019
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female