MAUDE Adverse Event Report: EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3.5, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-022-51-3513
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: 200-02-32 three peg patella 32mm: sn# (b)(6), 02-020-13-0335 - truliant cr cem fem cr cem right sz 3.5: sn# (b)(6), 02-022-45-3525 - truliant tib fit tray cem sz 3.5f / 2.5t: sn# (b)(6).The product associated with the reported event is within the scope of recall z-0023-2022 ; however, there is insufficient information to evaluate whether the subject issue of the recall was a cause or contributor to the reported event.The revision reported was likely the result of prosthesis wear of the tibial insert and inclusion of the polyethylene implants in the packaging recall.Additional reasons for the reported revision may be prosthesis wear of the patellar component, but this cannot be confirmed from the provided information.Possible causes for polyethylene damage include malalignment between implants, third body wear, patient-related conditions, inclusion of the polyethylene in the packaging recall, or any combination of these possibilities.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and relevant clinical information were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial total knee replacement on the right side.Subsequently, the patient experienced radiolucent osteolysis and pain.As a result, approximately four years post-surgery, the patient underwent a revision.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available at this time.This is report 2 of 2 for this event/patient.

• Brand Name: TRULIANT TIB IMP CRC INSERT SZ 3.5, 13MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville, FL 32653
• MDR Report Key: 22998640
• Report Number: 1038671-2025-02888
• Device Sequence Number: 9413869
• Product Code: JWH
• UDI-Device Identifier: 10885862307712
• UDI-Public: 10885862307712
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 02-022-51-3513
• 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: 09/05/2025
• Initial Report FDA Received Date: 09/08/2025
• Date Device Manufactured: 07/08/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female