MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0335
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Swelling/ Edema (4577); Aseptic loosening (4883)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the exactech truliant knee clinical study and operative notes, the patient underwent bilateral total knee replacement surgery.The patient had initially done well but started having increased pain and swelling.An infection workup was negative.Approximately 4 years and 4 months post the initial surgery; the patient¿s right knee was revised to non-exactech components due to suspected polyethylene wear and femoral component loosening.Per the operative notes, there was a typical synovitis with particulate debris and the synovial tissue in the medial and lateral gutters.There was brownish discoloration as well and looked gritty.Surgeon debrided this synovial tissue and sent a sample of the tissue for culture.There were no signs of purulence or infection.On gross inspection, there was no significant wear (to the tibial insert).There were some pitting changes in the articular surface, primarily medially and the femoral component was disimpacted without any difficulties as there was no attachment to the cement mantle.Additionally, there was gross damage to the patellar button.The patient was awakened from anesthesia and transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
D10: 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t, (b)(6).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.A review of complaint history determined that no further action is required as no trends were identified.The investigation results concluded that the reported event occurred due to polyethylene wear and femoral loosening as stated in the operative notes and clinical study documentation.The femoral loosening may have been the result of an insufficient bond between the femoral component and the bone.The extent and root cause of the reported polyethylene wear cannot be determined as the devices were not available for evaluation and images of the explanted devices and pre-revision radiographs were not 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 PS CEM FEM PS CEM RIGHT SZ 3.5
• 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 66th ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 25150239
• Report Number: 1038671-2026-00577
• Device Sequence Number: 10750199
• Product Code: JWH
• UDI-Device Identifier: 10885862314550
• UDI-Public: 10885862314550
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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 Catalogue Number: 02-020-11-0335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2022
• Initial Report FDA Received Date: 05/12/2026
• Date Device Manufactured: 08/31/2018
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: Black Or African American