MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS; SEE H10

Model Number	TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Osteolysis (2377); Implant Pain (4561); Joint effusion (4849); Aseptic loosening (4883)
Date of Event	10/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Concomitants: 5322236, 02-020-11-0235 - truliant ps cem fem ps cem left sz 3.5; 5337196, 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t; 5293903, 200-07-32 - advanced patella 32mm 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 legal notification, that patient, underwent initial bilateral knee replacement surgery on (b)(6) 2018 and was implanted with a truliant posterior stabilized tibial insert in both his right and left knees.Following the surgery, plaintiff began experiencing increasing chronic knee pain in both knees that steadily became worse.Plaintiff also reported stiffness, swelling, inflammation, nonreciprocal gait, and an inability to use stairs without experiencing severe pain in both knees.Plaintiff¿s physician informed plaintiff that due to exactech¿s recall of plaintiff¿s knee implant, plaintiff ¿may be dealing with some early wear and inflammatory response inside both knees¿ and may be experiencing ¿loose femoral components with the bonding of the femur from the cement mantle.¿ plaintiff¿s physician suggested revision surgery and explained that the surgery ¿would be a full revision if "[plaintiff]" is found to have a loose femoral component at the time of surgery.¿ plaintiff was diagnosed with ¿failed "[left]" tka due to a recalled polyethylene insert and possible femoral loosening.¿ plaintiff¿s physician recommended undergoing a left knee revision surgery first due to plaintiff¿s left knee presenting as ¿a little bit more unstable,¿ and then going on to undergo a right knee revision surgery several months later after once plaintiff had regained enough strength.Thus, due to this worsening pain, swelling, instability, and the recalled exactech knee device, plaintiff underwent a left knee replacement revision surgery on (b)(6) 2022, approximately 4 years 4 months post initial procedure, to remove the defective truliant device.During the left knee revision surgery, plaintiff¿s orthopedic surgeon noted there was ¿synovitis consistent with polyethylene wear¿ and on inspection of the removed tibial insert ¿there was some burnishing and early mild wear on the medial articular surface¿.Upon information and belief, the loose components and significant synovitis were due to a ¿failed left total knee arthroplasty secondary to aseptic loosening of the femoral component, polyethylene wear due to a recalled polyethylene insert with early femoral osteolysis.¿.No device return anticipated due to this being a legal case.No further information.
Event or Problem Description
Revision operative report of (b)(6) 2022.Patient was revised to competitor¿s devices.Failed left tka secondary to aseptic loosening of the femoral component, premature polyethylene wear due to a recalled polyethylene insert with early femoral osteolysis.¿there was also synovitis consistent with polyethylene wear."[the patellar button]" was in good condition and well fixed.On inspection, there was some burnishing and early mild wear on the medial articular surface.There were some osteolytic lesion in the medial and lateral femoral condyles.¿ the patient was transferred to the recovery room in stable condition.There is no other information available.
Additional Manufacturer Narrative
These devices are used for treatment not diagnosis.No other information is available.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of prosthesis wear, osteolysis, and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The extent and root cause of the prosthesis wear, osteolysis, and femoral loosening could not be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: TRULIANT PS
• Common Device Name: SEE H10
• 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: 16486433
• Report Number: 1038671-2023-00354
• Device Sequence Number: 5659830
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2026
• Device Model Number: TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
• Device Catalogue Number: 02-022-35-3511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 09/22/2023; 09/22/2023; 09/13/2026
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 09/22/2023; 09/27/2023; 09/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2018
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male