MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT KNEE COMPONENTS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	TRULIANT TIB IMP CR INS STD SZ 2, 9MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bacterial Infection (1735); Pain (1994); Swelling/ Edema (4577); Medical device site infection (4845)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient is verified right knee on (b)(6) 2016, which was revised on (b)(6) 2022.She was admitted back in the hospital (b)(6) 2023 (approximately 5 months after revision surgery) and ct rle with/without contrast showed small suprapatellar joint effusion, thick walled popliteal fluid collection.Mri r knee with/without contrast showed small r effusion with synovitis, complex baker's cyst.She underwent ct guided drainage per ir with cultures negative.Findings: there is substantial activity surrounding the prosthetic components of the right knee, particularly the femoral and patellar prosthetic components.Impression: substantial right knee periprosthetic activity potentially related to prosthesis loosening or recent installation/revision.Infected prosthesis is also considered.Patient was discharged home on (b)(6) 2023.She continued to have increased pain and swelling therefore she was referred to another doctor for further management.She underwent aspiration of r knee as an intervention.On admit she was afebrile.She was noted to have leukocytosis, wbc 18.7.She underwent right knee revision (b)(6) 2023 , approximately 6 months after their 1st revision.Synovial fluid purulent with surgical cultures negative with gram (+) bacilli on gs.Pre/post operative diagnosis: right knee infection, status post total knee arthroplasty.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H10.Additional/updated information ¿ b3 23 mar 2023, d5, h6.Medical device problem code.H6.Investigation results- the cause of the patient's condition/revision and infection as related to the devices cannot be conclusively determined.The sterilization documentation for truliant tib imp cr ins std sz 2, 9mm, sn (b)(6) was reviewed, the device was properly processed before distribution.These devices are used for treatment not diagnosis.H11.Correction- f10- should be blank.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b2, d1, d4, e1, e2, e3, g4, h6 - health effect - clinical code, health effect - impact code, component code, type of investigation and h11 the reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Medical records were provided for review.The review identified no abnormalities in usage or surgical technique performed.A definitive root cause was unable to be determined with the information 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 KNEE COMPONENTS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523782617
• MDR Report Key: 16778059
• Report Number: 1038671-2023-00768
• Device Sequence Number: 17810034
• Product Code: JWH
• UDI-Device Identifier: 10885862306272
• UDI-Public: 10885862306272
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/15/2026

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: 04/11/2026
• Device Model Number: TRULIANT TIB IMP CR INS STD SZ 2, 9MM
• Device Catalogue Number: 02-022-47-2009
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 01/17/2024; 04/08/2026
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 01/17/2024; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2018
• 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; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 68 KG