MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CR FEMORAL CEM, LEFT SZ 1

Model Number	02-010-03-0210
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.No information provided in the following section(s): age or date of birth, ethnicity, relevant tests/laboratory data, including dates.
Event or Problem Description
As reported, approximately 3 years and 2 months after the insertion of a left femoral component using high viscosity bone cement in the right knee of an overweight female patient, this patient presented to another surgeon with pain in her knee.The patient was revised.Photos of the removed femoral component (reviewed by the initial implanting surgeon) was noted to have no cement on it.He did not see a photo of the polyethylene.This same surgeon stated upon review of the post x-rays, it is hard to judge as to l v.R due to this small size component.Devices will not be returned.No other information available at this time.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation of the of the revision reported was likely the result of failure of the high viscosity cement used to secure the femoral component to the femoral bone, which led to loosening at the cement-implant interface and the reported pain.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CR FEMORAL CEM, LEFT SZ 1
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10874732
• Report Number: 1038671-2020-00627
• Device Sequence Number: 19820708
• Product Code: JWH
• UDI-Device Identifier: 10885862157973
• UDI-Public: 10885862157973
• Combination Product (Y/N): N
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 11/09/2022
• Device Model Number: 02-010-03-0210
• Device Catalogue Number: 02-010-03-0210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10; SEE H10
• Outcome Attributed to Adverse Event: Required Intervention