MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 4.5 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-4512
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Joint effusion (4849)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitants: (b)(6), 02-022-45-4545 - truliant tib fit tray cem sz 4.5f/4.5t.(b)(6), 201-78-18 - holding pin headless no ribs w/30 deg pt 4 pack.H3 - the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that approximately 69 months after a left total knee replacement procedure, the patient underwent a revision procedure to address persistent and increasing size of the effusion with weightbearing pain.Revision surgery operative notes were provided.Preoperative diagnosis: 1.Failed left total knee arthroplasty secondary to polyethylene wear.Postoperative diagnosis: 1.Failed left total knee arthroplasty secondary to polyethylene wear.2.Aseptic loose femoral component.The patient is a 61-year-old gentleman who is a few years status post primary left total knee arthroplasty for osteoarthritis.He has had persistent and increasing size of the effusion recently with weightbearing pain.Infection workup has been negative.He is in the exactech recall and was felt to represent polyethylene wear and osteolytic debris.Description of procedure: there was synovitis.Subtotal synovectomy was performed.The patella was everted and found to be oxidated and delaminated.It was then resected just beneath the cement for a residual thickness of 15mm.Previous 12 insert was removed.Femoral component was tested at this point with a retrograde disimpaction and easily popped off the intact cement mantle.Tibia was well fixed.The patient was revised to exactech devices.The patient was awakened and taken to recovery in stable condition.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The reason for the revision was likely the result of the reported pain caused by an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.Or due to inclusion of the polyethylene in the packaging recall.Failure of the cement used to secure the femoral component to the femoral bone, may have lead to loosening at the cement-bone interface and/or cement-implant interface; however, this cannot be confirmed.The wear on the tibial insert and patella implants could not be confirmed from the provided images.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 PS INSERT SZ 4.5 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; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 22044276
• Report Number: 1038671-2025-02089
• Device Sequence Number: 9061309
• Product Code: JWH
• UDI-Device Identifier: 10885862304551
• UDI-Public: 10885862304551
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 05/30/2025

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 Expiration Date: 02/01/2026
• Device Catalogue Number: 02-022-35-4512
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 98 KG