MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP PS INSERT SZ 6 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-35-6010
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Joint effusion (4849)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending investigation.D10: 5690630 02-022-45-6050 - truliant tib fit tray cem sz 6f / 5t.
Event or Problem Description
As reported, approximately 5 years post op initial right tka, this 75 y/o male patient was revised due to a loose femur and recalled poly.Patient complaint of pain.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e.The revision reported was likely the result of patellar prosthesis wear and due to the reported femoral loosening.Failure of the cement used to secure the femoral component to the femoral bone, may have led to loosening at the cement-implant and/or cement-bone interface; however, this cannot be confirmed.Possible causes for polyethylene wear include maltracking between the patella and the femoral component, patient-related conditions, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.As the suspect device was not provided, these potential causes or their contribution to the sequence of events cannot be confirmed.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRULIANT TIB IMP PS INSERT SZ 6 10MM
• 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: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20004217
• Report Number: 1038671-2024-02938
• Device Sequence Number: 7433402
• Product Code: JWH
• UDI-Device Identifier: 10885862304711
• UDI-Public: 10885862304711
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 06/15/2026
• Device Catalogue Number: 02-022-35-6010
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2018
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male