MAUDE Adverse Event Report: EXACTECH, INC. LOGIC FEMORAL PS POR RIGHT SZ 2; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-02-0320
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Ambulation or Postural Difficulties (2544); Joint Laxity (4526); Implant Pain (4561); Joint effusion (4849)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right knee was revised due to evolving chronic laxity, functional impairment instability, femoral metaphyseal pain, chronic hydrarthrosis , cysts and wear of pe insert with femoral geode cavity femoral loosening.Patient was last known to be in stable condition following the event.No other patient information/medical information provided.Unable to obtain photos/x-rays.Devices have been returned.
Additional Manufacturer Narrative
Report number: 1038671-2023-01093.G4: 510k: k123687 and k140302.Multiple mdr reports were filed for this event, please see associated reports: 1038671-2023-01093.The revision reported was likely the result of gross instability, patient-related conditions, malalignment between the femoral and tibial components, an insufficient bond between the femoral component and bone, or any combination of these possibilities, which polyethylene wear of the tibial insert and aseptic (noninfected) femoral loosening.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LOGIC FEMORAL PS POR RIGHT SZ 2
• 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 court; gainesville, FL 32653
• MDR Report Key: 21343517
• Report Number: 1038671-2025-00773
• Device Sequence Number: 7741218
• Product Code: JWH
• UDI-Device Identifier: 10885862001399
• UDI-Public: 10885862001399
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• 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): 02/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2020
• Device Catalogue Number: 02-010-02-0320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female