MAUDE Adverse Event Report: Exactech, Inc. TRULIANT CR POR FEM CR POR RIGHT SZ 3.5; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Co

Catalog Number	02-020-14-0335
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient underwent a right knee replacement.Subsequently, the patient was revised.The press-fit femoral component did not achieve adequate fixation.The polyethylene insert was removed, and the femoral component was evaluated and found to be loose.Photographs provided showed evidence wear.The femoral component was removed, and a size 3 cck femoral component was implanted.The patient was last known to be in stable condition following the event.No further information is available.

• Brand Name: TRULIANT CR POR FEM CR POR RIGHT SZ 3.5
• Common Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Co
• Manufacturer (Section D): Exactech, Inc.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): Exactech; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66 ct; gainesville, FL 32653 ; +1(352)377-1140
• MDR Report Key: 50068205
• Report Number: 1038671-2026-00948
• Device Sequence Number: 10078032
• Product Code: MBH
• UDI-Device Identifier: 10885862315120
• UDI-Public: 10885862315120
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 07/29/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-020-14-0335
• Device Lot Number: 406788008
• 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: 07/09/2026
• Initial Report FDA Received Date: 07/29/2026
• 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: Hospitalization
• Patient Sex: Male