MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS CEM FEM PS CEM LEFT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-11-0250
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Joint effusion (4849)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 3.5 years post op the initial left tka, this male patient was revised due to pain.Patient had a loose femur and recalled poly.No breakage of device or surgical delay.Patient was last known to be in stable condition following the event.No other patient information/medical history reported.X-ray & photo are attached.Product is not returning, due to recall hospital will not release implants.
Additional Manufacturer Narrative
(d10) concomitant device(s): (b)(6) 02-022-35-5011 - truliant tib imp ps insert sz 5 11mm.(b)(6) 02-022-45-5040 - truliant tib fit tray cem sz 5f / 4t.(b)(6) 200-07-35 - advanced patella 35mm 3 peg implant.(b)(6) 521-78-36 - threaded pin size 5.1 collarless 2pk.The revision reported was likely the result of polyethylene wear, femoral loosening, and pain as stated in the operative notes and experience report.However, the photographed tibial insert does not appear to show signs of wear that are inconsistent with implantation.The aseptic (non-infected) femoral loosening may have been the result of an insufficient bond between the femoral component and/or patient-related conditions & nbsp; a contributing factor to the revision may have been inclusion of the implanted polyethylene component in the packaging recall.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 LEFT SZ 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 24387769
• Report Number: 1038671-2026-00170
• Device Sequence Number: 16004509
• Product Code: JWH
• UDI-Device Identifier: 10885862314475
• UDI-Public: 10885862314475
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2026

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: 02-020-11-0250
• 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: 02/27/2023
• Initial Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 08/09/2019
• 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: 60 YR
• Patient Sex: Male