MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 2 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-2009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Discomfort (2330); Ambulation or Postural Difficulties (2544); Balance Problems (4401); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via legal documentation that approximately 21 months after a right total knee replacement procedure, the patient has experienced daily pain and discomfort in her right knee; swelling; gait impairment; poor balance; component part loosening; and other injuries presently undiagnosed.The patient underwent a revision procedure to address infection and component part loosening.It was noted the patient was revised to a competitor's femoral component.No medical or surgical interventions were reported.No additional information is available.
Additional Manufacturer Narrative
D10: concomitant devices: (b)(6), 02-022-45-2010 - truliant tib fit tray cem sz 2f / 1t, (b)(6), 02-020-11-0320 - truliant ps cem fem ps cem right sz 2, (b)(6), 200-02-32 - three peg patella 32mm, (b)(6), 201-78-15 - holding pin mini sharp point 4 pk.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
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, h6.Mdr section codes updated/corrected: b, c, d.The revision reported was likely the result of an infection.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to patient conditions.The reported loosening may have been the result of an insufficient bond between the implant and the bone which led to femoral loosening.Based on length of implantation, the reason for revision appears unlikely to be secondary to prosthesis wear.However, this cannot be confirmed because the component was not returned for evaluation.It is unclear if the reported infection may have contributed to the loosening of the device.Additionally, this tibial insert was included in the polyethylene packaging recall which may have led to prosthesis wear, however this cannot be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs and relevant clinical information were not provided.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 PS INSERT SZ 2 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: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653 ; 3525541928
• MDR Report Key: 21900724
• Report Number: 1038671-2025-01885
• Device Sequence Number: 4084748
• Product Code: JWH
• UDI-Device Identifier: 10885862304063
• UDI-Public: 10885862304063
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• 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): 06/06/2025

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 Expiration Date: 09/21/2025
• Device Catalogue Number: 02-022-35-2009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2017
• 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
• Patient Sex: Unknown