MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 4, 9MM; SEE H10

Catalog Number	02-022-44-4009
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	09/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer.Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported via a legal notification that a patient, initial bilateral knees implanted on (b)(6) 2016, underwent a revision procedure on his left knee on (b)(6) 2019, in which he was implanted with a recalled truliant psc tibial insert.On (b)(6) 2022, the plaintiff underwent a second revision surgery on his left knee for issues including but not limited to polyethylene wear, bone loss, osteolysis, instability, and/or component loosening.The plaintiff¿s revision surgeries were due to accelerated and preventable wear of the optetrak and truliant polyethylene tibial inserts.The plaintiff experiences daily pain and discomfort in his left knee which limits his activities of daily living and impacts his quality of life.As a direct, proximate, and legal consequence of the defective nature of the device as described herein, the plaintiff has suffered and continues to suffer permanent and debilitating injuries and damages, including but not limited to, significant pain and discomfort; gait impairment; poor balance; difficulty walking; component part loosening; soft tissue damage; bone loss; and other injuries presently undiagnosed, which all require ongoing medical care.No device returns anticipated due to this being a legal case.No further information.First revision reported under (b)(4).
Additional Manufacturer Narrative
Product information has been identified.As a result, the following fields have been updated: d1, d4, g4, h4, h7, and h9.Added information to e3 and e4.Further information and/or investigation results will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of prosthesis wear and patient-related conditions.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, the patient experienced loosening, prosthesis wear and instability.As a result, the patient underwent an additional left knee revision approximately 2 years and 10 months after previous revision.No further patient impact reported.No further information available.

• Brand Name: TRULIANT TIB IMP PSC INSERT SZ 4, 9MM
• Common Device Name: SEE H10
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16457504
• Report Number: 1038671-2023-00280
• Device Sequence Number: 17770939
• 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: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/11/2026

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: 03/28/2026
• Device Catalogue Number: 02-022-44-4009
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 09/25/2023; 05/18/2026
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 09/27/2023; 10/05/2023; 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown