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

Catalog Number	02-010-04-0235
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitants: lgc tibial fit tray cem sz 3.5f / 4.5t - 02-012-45-3545 - 4869480.Logic cr femoral por, left, sz 3.5 - 02-010-04-0235 - 4416761.Three peg patella 38mm - 200-02-38 - 6067814.H3: the revision reported was likely the result of presumed prosthesis wear of the tibial insert and the patella, and an insufficient bond between the femoral component and the bone, which led to aseptic (non-infected) femoral loosening.However, this cannot be confirmed as the devices were not returned for evaluation.
Event or Problem Description
It was reported, a 64 yo male patient, initial left knee implanted on (b)(6), 2022, underwent a revision procedure on (b)(6) 2024, approximately 1 year 7 months post the initial procedure.The patient was revised due to femur loosing from poly and patella wear.Everything was removed.There were no device breakages or surgical delay during the procedure.The patient was last known to be in stable condition following the event.X-rays provided.No devices returning for analysis.They were discarded at the hospital.Device images were provided.No further information.This was the 2nd revision for this patient.1st revision reported under mdr# 1038671-2022-01115.

• 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: 19833478
• Report Number: 1038671-2024-02548
• Device Sequence Number: 7504948
• Product Code: JWH
• UDI-Device Identifier: 10885862158260
• UDI-Public: 10885862158260
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 07/25/2024

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: 05/18/2021
• Device Catalogue Number: 02-010-04-0235
• 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: 03/28/2024
• Initial Report FDA Received Date: 07/25/2024
• Date Device Manufactured: 05/20/2016
• 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 Age: 64 YR
• Patient Sex: Male