MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT PS POR FEM PS POR RIGHT SZ 4.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-020-12-0345
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1.5 years post initial tka, the patient had pain starting a few weeks after surgery.Patient is dissatisfied with implant function.Tibia was loose with only fibrous ingrowth.Femur also had minimal bone ingrowth.There was no breakage of the device.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos and x-rays.The devices are not available for evaluation due to recall hospital will not release.
Additional Manufacturer Narrative
D10: concomitants: 5316760 02-022-35-(b)(6) - truliant tib imp ps insert sz 4.5 9mm.5758187 02-020-12-(b)(6) - truliant ps por fem ps por right sz 4.5.6022415 02-022-55-(b)(6) - truliant por tib tray size 4.5f/3.5t.6857967 200-07-32 - advanced patella 32mm 3 peg implant.The revision reported may have been the result of an insufficient bond between the implants and the bone, poor bone quality, patient-related conditions, or any combination of these possibilities, which led to aseptic (non-infected) loosening and pain.However, this cannot be confirmed as the devices were not available for evaluation and pre-revision radiographs were unable to be obtained.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 POR FEM PS POR RIGHT SZ 4.5
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 24456156
• Report Number: 1038671-2026-00193
• Device Sequence Number: 13263819
• Product Code: JWH
• UDI-Device Identifier: 10885862314925
• UDI-Public: 10885862314925
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: 02-020-12-0345
• 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: 10/06/2022
• Initial Report FDA Received Date: 02/26/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female