MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-3009
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 02-020-11-0330 - truliant ps cem fem ps cem right sz 3 (b)(6).02-022-45-3020 - truliant tib fit tray cem sz 3f / 2t (b)(6).200-02-32 - three peg patella 32mm (b)(6).201-78-15 - holding pin mini sharp point 4 pk (b)(6).203-96-64 - sawblades ez1913.M62 90x19, 1.27mm strkr5/6/7 (b)(6).521-78-23 - threaded pin size 2.3 collared 2pk (b)(6).521-78-32 - threaded pin size 3.0 collarless 2pk (b)(6).Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that a female patient, who had a left tka, underwent a revision procedure.The surgeon contacted the patient requesting they get a poly swap.The previously implanted poly was explanted and replaced with a different size.There were no surgical delays or device breakages during the procedure.The patient was last known to be in stable condition following the event.An x-ray was provided.The explanted device is not available for return as the hospital would not release them.No device images were able to be obtained.No further information.

• Brand Name: TRULIANT
• 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; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: ashley harris ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 24671208
• Report Number: 1038671-2026-00312
• Device Sequence Number: 10360253
• Product Code: JWH
• UDI-Device Identifier: 10885862304254
• UDI-Public: 10885862304254
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/23/2026

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: 02-022-35-3009
• 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: 03/06/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female