MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 3.5 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number	02-022-35-3511
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation, this patient had right knee replacement on (b)(6) 2017.Patient had right knee revision on (b)(6) 2023, approximately 5 years 3 months after their initial replacement.Postoperative diagnosis: failed right total knee polyethylene due to premature wear and polyethylene recall, as well as loose femoral component.There was found to be visible evidence of polyethylene wear with encapsulated polyethylene debris of the synovium.There was found to be a loose femoral component and well-fixed tibial and patellar components.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.
Additional Manufacturer Narrative
Pending investigation.Concomitant medical products: concomitants: 5040345 02-020-11-0335 - truliant ps cem fem ps cem right sz 3.5 4927039 02-022-45-3535 - truliant tib fit tray cem sz 3.5f / 3.5t 5100233 200-02-35 - three peg patella 35mm 4971588 204-34-02 - fluted stem extension 25l x 14 mm 4982916 204-70-00 - tibial stem ext.Screw.
Additional Manufacturer Narrative
H6: investigation results - the revision reported was likely the result of prosthesis wear and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.The extent and root cause of the reported prosthesis wear cannot be determined as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 3.5 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• 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 ; 3523782617
• MDR Report Key: 16880770
• Report Number: 1038671-2023-00918
• Device Sequence Number: 18007446
• Product Code: JWH
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/21/2025
• Device Model Number: 02-022-35-3511
• Device Catalogue Number: 02-022-35-3511
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 08/28/2023; 09/29/2026
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 09/15/2023; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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 Age: 77 YR
• Patient Sex: Male