MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 15MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3515
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's left knee was revised approximately 3 years 4 months post op.Patient complained of pain.Possible infection.Both the patella and insert used in initial surgery have been recalled.
Additional Manufacturer Narrative
(h3) pending evaluation.(d10) concomitant device(s): 02-012-60-1440 - tru stem ext 14mm x 40mm, (b)(6).02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t, (b)(6).02-020-11-0235 - truliant ps cem fem ps cem left sz 3.5, (b)(6).204-70-00 - tibial stem ext.Screw, (b)(6).200-07-32 - advanced patella 32mm 3 peg implant, (b)(6).
Additional Manufacturer Narrative
The revision reported was likely the result of infection, however this cannot be confirmed.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall and prosthesis wear.Localized deformation of the posterior lip of the tibial insert was noted, but overall, the insert was unremarkable for an implanted device.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.D4: corrected.D6: corrected.G4: corrected.H6: corrected component and investigation clinical codes.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3.5 15MM
• 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 ; 3523771140
• MDR Report Key: 20352511
• Report Number: 1038671-2024-03789
• Device Sequence Number: 8108315
• Product Code: JWH
• UDI-Device Identifier: 10885862304407
• UDI-Public: 10885862304407
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K192097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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 Catalogue Number: 02-022-35-3515
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 06/06/2025
• Date Device Manufactured: 10/12/2020
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female