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

Catalog Number	02-012-44-3011
Medical Device Problem Codes	Unstable (1667); Naturally Worn (2988)
Health Effect - Clinical Codes	Granuloma (1876); Joint Laxity (4526); Joint effusion (4849)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
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.
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 - (b)(6) - gps implant kit v2.
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.

• 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: 19802056
• Report Number: 1038671-2024-02473
• Device Sequence Number: 15540720
• Product Code: JWH
• UDI-Device Identifier: 10885862173560
• UDI-Public: 10885862173560
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110547
• 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
• Report Date (Section B): 08/02/2024

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 Expiration Date: 03/17/2025
• Device Catalogue Number: 02-012-44-3011
• 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
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2017
• 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
• Patient Sex: Male