MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3.5, 17MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-44-3517
Medical Device Problem Codes	Naturally Worn (2988); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Osteolysis (2377)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by legal, approximately 8 months post op the second revision of the left tka, this male patient underwent a third revision and the optetrak device was removed.Reason for the revision was not reported.Upon information and belief, patient required several revision surgeries for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening.
Additional Manufacturer Narrative
Pending manufacturer evaluation.
Additional Manufacturer Narrative
H3: the truliant device with serial number (b)(6), is confirmed to have been packaged in a vacuum bag that does not contain evoh.The cause of the patient's condition and revision surgery as related to the devices cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.
Additional Manufacturer Narrative
H3: investigation results - the revision reported was likely the result of prosthesis wear.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.The extent and root cause of the prosthesis wear could not be determined as the device was not returned for evaluation, and images and radiographs were not provided.
Event or Problem Description
It was reported that the patient underwent a left knee revision.Subsequently, it was reported that the patient experienced prosthesis wear and osteolysis.As a result, the patient underwent an additional revision approximately 8 months after the previous revision.No further patient impact reported.No further information available.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 3.5, 17MM
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16478790
• Report Number: 1038671-2023-00344
• Device Sequence Number: 3199124
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/17/2026

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 Expiration Date: 06/18/2026
• Device Catalogue Number: 02-022-44-3517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023; 12/04/2023; 09/17/2026
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/19/2023; 12/19/2023; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0023-2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: See H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male