MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	TRULIANT TIB IMP PSC INSERT SZ 4, 10MM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Wound Infection (2447); Swelling/ Edema (4577); Medical device site infection (4845)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer concomitants: a178176 02-020-11-0240 - truliant ps cem fem ps cem left sz 4.A171854 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t.A274407 200-07-35 - advanced patella 35mm 3 peg implant.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via exactech truliant knee clinical study, that a male patient, initial left knee implanted on (b)(6) 2023, underwent a poly revision procedure on (b)(6) 2023, due to a wound infection.Date of onset, (b)(6) 2023.The study indicated the patient was seen at a scheduled clinic appointment and was prescribed an oral antibiotic for mild prepatellar bursitis.The follow-up clinic visit on (b)(6) 2023, showed improvement in symptoms.On (b)(6) 2023, the patient stated they developed left knee edema, pain, and redness, and on (b)(6), 2023, they presented to the er for worsened symptoms.They were admitted to the hospital, and 3.375 g iv q8h was ordered.Wbc (b)(6) 2023 high @3:18 am 24.42 and @6:57 am 18.63.Ct with iv contrast reported large peripheral subcutaneous fluid collection anterior aspect of left knee suspicious for abscess.Small to moderate knee joint effusion with synovitis suspicious for septic arthritis.Knee joint aspiration recommended.Left knee surgery for drainage with exchange of poly liner ltka performed on (b)(6) 2023, for pyogenic arthritis of left knee joint, due to unspecified organism.Per pi exchange is soc for tka infection and upon careful inspection the appearance of the removed poly liner looked "normal".The patient had a post-poly liner exchange surgery clinic visit on (b)(6) 2023.Patient still on oral antibiotics, pain moderate 8/10 rating, severe left groin pain and struggles to walk with a walker.Minimal medial and lateral joint line and patellofemoral tenderness.Incisions healed well.Left hip x-rays showed severe arthritis with old pelvic fracture.Referred to larger facility like mayo clinic for left hip pain in need of tha evaluation.Pi clinic follow-up scheduled for 1 month after course of antibiotics completed.Outcome indicates continuing.No device return anticipated due to this being a clinical study no further information.
Additional Manufacturer Narrative
On (b)(6) 2023: subject had wound incision and drainage with explant of ltka and implantation of antibiotic spacer.Outcome: resolved.Resolution date: on (b)(6) 2023.
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, d4, h4, h6.Mdr section codes updated/corrected: b, c, d, e, g.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition and/or surgical procedure.Additionally, infection is a known surgical risk, as outlined in the ifu.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, 10MM
• 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: kate jacobson ; 3523771140
• MDR Report Key: 17031274
• Report Number: 1038671-2023-01179
• Device Sequence Number: 6459982
• Product Code: JWH
• UDI-Device Identifier: 10885862305275
• UDI-Public: 10885862305275
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2025

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 Model Number: TRULIANT TIB IMP PSC INSERT SZ 4, 10MM
• Device Catalogue Number: 02-022-44-4010
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 01/11/2024; 06/26/2025
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 02/06/2024; 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White