MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 67 yo female patient, initial right knee implanted on an unknown date, underwent a revision procedure on (b)(6) 2023.The patient was complaining of pain.They had an extensive amount of swelling typically worse towards the end of the day that did not improve by morning.On exam, the patient had a severe effusion, and the radiograph suggested that the medial compartment of the tka was narrower than the lateral compartment.Given the patient's symptoms, as well as the subtle changes with regards to the thickness of the polyethylene on the tka, the patient was sent to have a ct for further evaluation.The ct confirmed that the polyethylene height is slightly decreased with regard to the medial compartment when compared to the lateral.Following being examined, the decision was made to revise the polyethylene given the patient's symptoms and ct findings.The surgical approach was made through the existing medial parapatellar tka incision.No synovitis was noted in the soft tissue superficial to the arthrotomy.When the arthrotomy was made copious amounts of dark straw-colored joint fluid poured out of the joint.No synovitis was noted along the periosteum nor was there purulence within the joint fluid.A total of 2 cultures were taken during the case, both of which were negative for growth.Polyethylene was removed and appeared to have a yellow hue to it.A new polyethylene liner was placed, and the surgical exposure was closed.There were no surgical delays or device breakage reported.There were no complications with the revision of the polyethylene liner.The device is anticipated to return.No further information.
Additional Manufacturer Narrative
D2b: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, d4, d6a, h4, h6.Mdr section codes updated/corrected: b, c, d, e, g.The product associated with the reported event is within the scope of recall z-0023-2022; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The revision reported was likely the result of the pain and swelling as reported by the patient.The returned device does not exhibit signs of prosthesis wear.Additional contributions of user, and patient-related considerations to the event could not be assessed.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM
• 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: 16936168
• Report Number: 1038671-2023-00999
• Device Sequence Number: 5830027
• Product Code: JWH
• UDI-Device Identifier: 10885862307699
• UDI-Public: 10885862307699
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: 02-022-51-3509
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 85 KG