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

Model Number	02-020-11-0350
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post op the initial right tka, this 90 y/o male patient was revised due to a loose femur.Patient complained of pain.Patient was last known to be in stable condition following the event.No additional patient information reported.Devices not returning, hospital will not release.
Additional Manufacturer Narrative
Device evaluated by mfr: pending evaluation.Concomitant medical products: (b)(4), 02-012-60-1440 - logic stem ext 14mm x 40mm.(b)(4), 02-022-45-5050 - truliant tib fit tray cem sz 5f / 5t.(b)(4), 02-029-99-1001 - fluted headless pin 3.0" square head, pk2.(b)(4), 200-07-32 - advanced patella 32mm 3 peg implant.(b)(4), 204-70-00 - tibial stem ext.Screw.(b)(4), 02-022-35-5009 - truliant tib imp ps insert sz 5 9mm.
Additional Manufacturer Narrative
1038671-2025-00190 this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 (type of investigation, investigation findings, investigation conclusions) the following sections were corrected: h6 (health effect - clinical code).The reason for the revision reported cannot be confirmed from the information provided but may be the result of femoral loosening and prosthesis wear or due to 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 relevant clinical information 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 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 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 3523771140
• MDR Report Key: 16077004
• Report Number: 1038671-2022-01649
• Device Sequence Number: 17682287
• Product Code: JWH
• UDI-Device Identifier: 10885862314581
• UDI-Public: 10885862314581
• 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: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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 Model Number: 02-020-11-0350
• Device Catalogue Number: 02-020-11-0350
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male