MAUDE Adverse Event Report: EXACTECH, INC. LOGIC TIBIA PS MOD INSRT SZ 2 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-35-2013
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 73 yo female patient, initial left knee implanted in (b)(6) of 2019, who had an initial revision in (b)(6) of 2023 underwent a 2nd revision procedure in (b)(6) 2024, approximately 1 year 2 months post the may procedure due to wear on patella and tibial insert.The knee form diagnosis section indicates tibial insert wear and pitting.All devices were removed and replaced with a competitor¿s devices.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.No x-rays were able to be obtained.The devices are not available for evaluation as they were discarded at the hospital.Device images were provided.No further information.The initial revision has been reported under mdr #1038671-2023-01402.
Additional Manufacturer Narrative
D10: concomitants: (b)(6) 02-012-45-2020 - lgc tibial fit tray cem sz 2f / 2t.(b)(6) 02-010-01-0220 - lgc femoral ps cem left sz 2.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: g1 - contact email, g3, g6, h1/h2, h3, and h6 - component code, type of investigation, and investigation findings and conclusion.The revision reported was likely the result of presumed prosthesis wear of the tibial insert and patella component.However, images of the revised insert do not show signs of excessive prosthesis wear inconsistent with being implanted, no radiographs were provided, and the revised components were not returned to exactech for evaluation.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.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2024-02563.The revision reported was likely the result of presumed prosthesis wear of the tibial insert and patella component.However, images of the revised insert do not show signs of excessive prosthesis wear inconsistent with being implanted, no radiographs were provided, and the revised components were not returned to exactech for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC TIBIA PS MOD INSRT SZ 2 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 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville 32653 ; 3525541928
• MDR Report Key: 19838913
• Report Number: 1038671-2024-02562
• Device Sequence Number: 7877611
• Product Code: JWH
• UDI-Device Identifier: 10885862001740
• UDI-Public: 10885862001740
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2025

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: 02-012-35-2013
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 11/08/2024; 11/08/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 12/02/2024; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 55 KG