MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 5 9MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-5009
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1038671-2022-01649.D10: concomitant devices: (b)(6), 02-012-60-1440 - logic stem ext 14mm x 40mm; (b)(6), 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t ; (b)(6), 02-029-99-1001 - fluted headless pin 3.0" square head, pk2; (b)(6), 200-07-32 - advanced patella 32mm 3 peg implant; (b)(6), 204-70-00 - tibial stem ext.Screw.The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening and prosthesis wear or due to inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation 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.
Event or Problem Description
As reported, approximately 1.5 years post op the initial right tka, this 90 y/o male patient was revised due to a loose femur.Patient complained of pain.Patient was last known to be in stable condition following the event.No additional patient information reported.Devices not returning, hospital will not release.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21124625
• Report Number: 1038671-2025-00190
• Device Sequence Number: 8760073
• Product Code: JWH
• UDI-Device Identifier: 10885862304612
• UDI-Public: 10885862304612
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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: 02-022-35-5009
• 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: 12/09/2022
• Initial Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 11/19/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male