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

Catalog Number	02-022-47-3509
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Synovitis (2094); Joint Laxity (4526); Swelling/ Edema (4577); Joint effusion (4849)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 6172622 02-020-13-0335 - truliant cr cem fem cr cem right sz 3.5 5657649 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t 6186720 200-07-32 - advanced patella 32mm 3 peg implant.
Event or Problem Description
It was reported that this 67 y/o female patient's right knee was revised approximately 3 years 9 months post op.The patient had an original exactech tka.The patient returned to surgeons office with complaints of pain, swelling, instability, and dissatisfaction with their tka.The patient has a recalled poly implant.Upon examination, the patient was scheduled to have a revision tka possible poly swap vs full revision.The patient had revision surgery on (b)(6) 2024.The patient underwent poly tibial insert swap and patella swap.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d4, h6.Mdr section codes updated/corrected: a, b, c, d, e, g.The reason for the revision reported was likely due to the instability or due to the inclusion of the polyethylene in the packaging recall.Instability may be the result of increased soft-tissue laxity (looseness), inadequate flexion of the implants, or improper positioning or alignment of the prosthesis.Prosthesis wear of the tibial insert and the patella, could not be confirmed from the provided images.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 CR INS STD SZ 3.5, 9 MM
• 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19306593
• Report Number: 1038671-2024-01222
• Device Sequence Number: 15062446
• Product Code: JWH
• UDI-Device Identifier: 10885862306425
• UDI-Public: 10885862306425
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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 Expiration Date: 02/01/2025
• Device Catalogue Number: 02-022-47-3509
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female