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

Catalog Number	02-020-11-0240
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Inflammation (1932); Pain (1994); Scar Tissue (2060); Synovitis (2094); Joint effusion (4849)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 2 years post op the initial left tka, this 53 y/o female patient was revised due to a loose femur.Patient complained of pain.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 02-012-60-1425, 5889727 - logic stem ext 14mm x 25mm; 02-022-35-4009, 5207846 - truliant tib imp ps insert sz 4 9mm; 02-022-45-4030, 6408554 - truliant tib fit tray cem sz 4f / 3t; 02-029-99-1001, 360341 - fluted headless pin 3.0" square head; 200-07-32, 6504926 - advanced patella 32mm 3 peg implant; 204-70-00, 6490213 - tibial stem ext.Screw.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not available for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e.The revision reported may have been due to the result of an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening, prosthesis wear, and/or due to inclusion of the polyethylene in the packaging recall.However, the reported femoral loosening and prosthesis wear could not be confirmed.Additionally, potential contributions of user and additional patient-related considerations to the event could not be assessed as the devices were not available for evaluation and radiographs were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: TRULIANT PS CEM FEM PS CEM LEFT 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 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15326561
• Report Number: 1038671-2022-00981
• Device Sequence Number: 20423528
• Product Code: JWH
• UDI-Device Identifier: 10885862314451
• UDI-Public: 10885862314451
• 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: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-020-11-0240
• 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: 08/11/2022
• Supplement Date Received by Manufacturer: 03/30/2023; 10/06/2025
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 04/19/2023; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female