MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-44-4012
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	02/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: (b)(6), 02-020-11-0340 - truliant ps cem fem ps cem right sz 4, (b)(6), 02-022-44-4012 - truliant tib imp psc insert sz 4, 12mm, (b)(6), 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t, (b)(6), 200-02-38 - three peg patella 38mm, (b)(6), 02-022-44-4012 - truliant tib imp psc insert sz 4, 12mm, (b)(6), 203-96-52 - stryker kms2512.M62 90x25x1.19mm.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a patient, right knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2025, approximately 5 years 2 months post the initial procedure.The patient was revised due to pain.The tibia was revised with stem and augments.Tibia was revised due to wear and osteolysis.It was stated there were no issues with the surgery.X-rays were not provided.Explanted devices are not available for return.A device image was provided.No further information available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1, d4, d6a, g4, h4, h6 mdr section codes updated/corrected: b, c, d the reason for the revision reported cannot be confirmed from the information provided but may be due to the reported pain or inclusion of the polyethylene in the packaging recall.The reason for the clinical symptom of the reported pain cannot be conclusively determined.Prosthesis wear of the tibial insert could not 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 PSC INSERT SZ 4, 12MM
• 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
• MDR Report Key: 21510613
• Report Number: 1038671-2025-01371
• Device Sequence Number: 18133355
• Product Code: JWH
• UDI-Device Identifier: 10885862305299
• UDI-Public: 10885862305299
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• 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): 09/26/2025

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 Catalogue Number: 02-022-44-4012
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown