MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-45-3040
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Granuloma (1876); Joint Laxity (4526); Joint effusion (4849)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient, initial left knee implanted on (b)(6) 2019, underwent a revision procedure on (b)(6) 2024, approximately 4 years 8 months post the initial procedure.The patient was suffering from laxity, instability, and chronic hydrarthrosis.Macroscopic pe granuloma indicated.The report stated the patient had aseptic tibial and femoral loosening 5 years after the initial placement.The pe was changed.No surgical delays or device breakages were reported.No x-rays were provided.The device return status for analysis is unknown currently.They have been requested.No device images were provided.No further information.
Additional Manufacturer Narrative
D10: concomitants: 5893383 - 200-02-41 - implant patellaire 3 plots, 5705289 - 204-34-04 - tige extension diam 14 lg 40, 5743666 - 04-70-00 - vis pour tige extension tibiale, 2028019157 - a10012 - gps implant kit v2,.
Additional Manufacturer Narrative
H3: the revision reported was likely the result of prosthesis wear and insufficient bonds between the components and the bones, which led to aseptic (non-infected) femoral and tibial loosening.Possible causes for polyethylene wear include malalignment between the implants, high contact stresses during knee flexion, third body wear, patient-related conditions, instability, or any combination of these possibilities.However, this cannot be confirmed as the devices were not returned for evaluation, and images and radiographs were not provided.

• Brand Name: OPTETRAK LOGIC
• 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 ; 3525541928
• MDR Report Key: 19801708
• Report Number: 1038671-2024-02472
• Device Sequence Number: 15334737
• Product Code: JWH
• UDI-Device Identifier: 10885862003973
• UDI-Public: 10885862003973
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/17/2024

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: 02-012-45-3040
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 07/29/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/02/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male