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

Model 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); Pain (1994)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): s035099, 02-022-35-4009 - truliant tib imp ps insert sz 4 9mm; 6222387, 02-022-45-4040 - truliant tib fit tray cem sz 4f / 4t; 6190986, 200-07-35 - advanced patella 35mm 3 peg implant.
Event or Problem Description
As reported, approximately 3 years post op the initial left tka, this 75 y/o male patient was revised due to a loose femur.Patient complained of pain.Due to recall surgeon used a competitor for revision.Patient was last known to be in stable condition following the event.Product not returning, due to recall hospital will not release the implants.
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 and pain.However, this cannot be confirmed as the device was not returned for evaluation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, g1, h6 - health effect - clinical code, type of investigation, investigation findings and investigation conclusions.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 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: geoff gannon ; 3523771140
• MDR Report Key: 15494195
• Report Number: 1038671-2022-01174
• Device Sequence Number: 13951943
• 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: 2019
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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 Model Number: 02-020-11-0240
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 02/28/2023; 02/18/2026
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 03/21/2023; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male