MAUDE Adverse Event Report: EXACTECH, INC. TRU CC TIB INSERT SIZE 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-65-4013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Per a report from the legal department, the patient had an initial right knee implanted.The patient had two revisions of the right knee.Op report pre & post op diagnosis: failed total right knee replacement.Indications: patient had severe pain due to failed aseptic loosening of total right knee replacement.Pt has failed conservative treatment and wished to undergo operative intervention.Risks, benefits, and alternatives discussed with patient.Despite potential risks, they wished to proceed with the operative intervention.Intraoperative findings: loose femoral implant - removed easily with minimal bone loss but concerned for bone quality distal femur.I elected to sue femoral cone.Tibial implant was very solid and well fixed - backslap device and osteotomes were used but stem would not budge - cortical window distal to the stem allowed me to hit the stem tip and knock it out retrograde.
Additional Manufacturer Narrative
1038671-2023-00660 the reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening.The reported prosthesis wear and femoral loosening could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: g3.The following sections were corrected: d4.The reason for the revision reported cannot be confirmed from the information provided but may be the result of prosthesis wear and femoral loosening.The reported prosthesis wear and femoral loosening could not be confirmed.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images and radiographs were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: TRU CC TIB INSERT SIZE 4, 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21021297
• Report Number: 1038671-2024-05006
• Device Sequence Number: 13044761
• Product Code: JWH
• UDI-Device Identifier: 10885862613493
• UDI-Public: 10885862613493
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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 Expiration Date: 01/24/2026
• Device Catalogue Number: 02-012-65-4013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• 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): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male