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

Model Number	TRULIANT TIB FIT TRAY CEM SZ 4F / 4T
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Scar Tissue (2060); Discomfort (2330); Joint Laxity (4526); Implant Pain (4561); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation and no medical or other records containing treatment information or patient information have been received; therefore, the reported event cannot be confirmed, nor can the circumstances or potential causes or contributors to the alleged event be evaluated.Should additional, material information become available that permits more analysis or conclusions, a supplemental report will be filed accordingly.D10 concomitants: 02-022-35-4009 - truliant tib imp ps insert sz 4 9mm, (b)(6).02-020-11-0340 - truliant ps cem fem ps cem right sz 4, (b)(6).200-07-32 - advanced patella 32mm 3 peg implant, (b)(6).A10012 - gps implant kit v2 1001220129.
Event or Problem Description
Additional information received from legal on 07aug2023.As reported via legal documentation the patient had a right knee replacement on (b)(6)2020.Approximately 2 years and 2 months after the initial procedure the patient had a right knee revision on (b)(6) 2022.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.Revision op report on 8 nov 2022.Diagnosis: failed right tka; right knee instability with varus stress findings: the quad was adherent anteriorly and a quadricepsplasty was required to free the extensor mechanism.The femoral component was well fixed but internally rotated.The tibial tray was in slight varus, but there was a noticeable gap at the cement bone interface concerning for loosening.Original description summary: legal case ¿ (b)(6).Implant date: (b)(6) 2020.Explant date: (b)(6) 2022.No device return anticipated due to this being a legal case.Unable to locate surgeon/patient/serial number in ebi.No serial numbers available.Historical record and smartsolve searched for sn/patient name with no results.No further information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that approximately 26 months after a right total knee replacement procedure, the patient underwent a revision procedure to address loosening, instability, implant pain, joint effusion, joint laxity, scar tissue and swelling/edema.Initial surgery and revision surgery operative notes were provided.Patient left the operating room in stable condition.No further issues or complications were reported.No additional information is available.

• Brand Name: TRULIANT TIB FIT TRAY CEM SZ 4F / 4T
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21218077
• Report Number: 1038671-2025-00364
• Device Sequence Number: 8639727
• Product Code: JWH
• UDI-Device Identifier: 10885862305886
• UDI-Public: 10885862305886
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TRULIANT TIB FIT TRAY CEM SZ 4F / 4T
• Device Catalogue Number: 02-022-45-4040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/19/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2020
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male