MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC CR FEMORAL CEM, RIGHT, SZ 2.5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-010-03-0325
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned for evaluation; the reported event was confirmed by review of photographs and radiograph images of the device.A review of manufacturing data was performed and no discrepancies were found.The revision reported was likely the result of prosthesis wear of the tibial insert and femoral loosening, as stated in the experience report.However, the images of the revised tibial insert do not show signs of extensive wear inconsistent with being implanted for nearly 3 years.The aseptic (non-infected) femoral loosening was likely due to an insufficient bond between the femoral implant and the bone, and failure of the cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface.The cause of the prosthesis wear and loosening cannot be determined as there were no details regarding cementing technique or environmental conditions provided and the revised components were not returned for evaluation.Concomitants: (b)(6) - 02-010-03-0325 - logic cr femoral cem, right, sz 2.5; (b)(6) - 02-012-45-2525 - lgc tibial fit tray cem sz 2.5f / 5t; (b)(6) - 200-02-35 - three peg patella 35mm.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Approximately 2 years 10 months post initial right knee implantation; it was reported that a patient underwent a revision procedure.The patient was revised due to femoral loosening and poly wear.The femur and liner were revised to a logic ps.There were no device breakages or surgical delays during the procedure.The patient was last known to be in stable condition following the event.Device images and x-rays were provided.No device returns for analysis available as the devices were disposed of by the hospital.No further information.

• Brand Name: OPTETRAK LOGIC CR FEMORAL CEM, RIGHT, SZ 2.5
• 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; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 20844010
• Report Number: 1038671-2024-04615
• Device Sequence Number: 18167832
• Product Code: JWH
• UDI-Device Identifier: 10885862230362
• UDI-Public: 10885862230362
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-010-03-0325
• 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: 02/22/2024
• Initial Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 05/30/2019
• 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
• Patient Sex: Female
• Patient Weight: 90 KG