MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM RIGHT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0340
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Synovitis (2094); Osteolysis (2377); Swelling/ Edema (4577)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 60 months after a right knee total replacement procedure, the patient has experienced prosthesis wear, chronic pain and swelling.Post operative report was provided.Intraoperatively, the surgeon observed polyethylene synovitis, scar tissue and wear of the patella button, wear of the polyethylene insert, lysis around the lateral condyle.No further issues or complications were reported.No other patient information/medical history reported.
Additional Manufacturer Narrative
D10: (b)(6), 02-022-45-4030 - truliant tib fit tray cem sz 4f / 3t; (b)(6), 200-07-29 - advanced patella 29m 3 peg implant; (b)(6), 02-022-35-4010 - truliant tib imp ps insert sz 4 10mm.Multiple mdr reports were filed for this event, please see associated report: 1038671-2023-01964.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.
Additional Manufacturer Narrative
Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01964 the revision reported was likely the result of femoral loosening.Additional reasons for the reported revision may be inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and 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 4
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20894714
• Report Number: 1038671-2024-04741
• Device Sequence Number: 18320287
• Product Code: JWH
• UDI-Device Identifier: 10885862314567
• UDI-Public: 10885862314567
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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 Catalogue Number: 02-020-11-0340
• 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: 12/23/2023
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2018
• 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: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female