MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 4, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-4011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a year after the initial surgery, the patient underwent a revision of the poly due to pitting.No further details provided.
Additional Manufacturer Narrative
Pending investigation.D10: 02-020-13-0240 - truliant cr cem fem cr cem left sz 4 6809095 200-02-29 - three peg patella 29mm a291357 02-022-45-4035 - truliant tray, cem sz 4f/3.5t a397783.
Additional Manufacturer Narrative
The reason for the revision reported may be related to prosthesis wear as slight pitting consistent with third bodies was noted on the provided images of the tibial insert; however, the device appears unremarkable for signs of volumetric wear and the insert would not have been at risk for increased oxidation as it was not packaged in a non-conforming bag/included in the packaging recall.However, the wear cannot be confirmed as the devices were not available for evaluation and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and limited information was provided.H6: corrected investigation clinical codes.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 4, 11MM
• 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: 20699028
• Report Number: 1038671-2024-04411
• Device Sequence Number: 3715058
• Product Code: JWH
• UDI-Device Identifier: 10885862307767
• UDI-Public: 10885862307767
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Catalogue Number: 02-022-51-4011
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 03/17/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male