MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CC FEMORAL SIZE 3, LEFT

Model Number	02-010-06-0230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: tibial insert (cat# 02-022-44-3009); tibial tray (cat# 02-022-45-3030); tibial stem extension (cat# 204-70-00); patellar (cat# 200-02-32).
Event or Problem Description
As reported by the exactech knee replacement study, the (b)(6) y/o female patient initially complained of severe pain and pressure to the left knee for three months.Patient weight is (b)(6) lbs.The patient was revised.The event is possibly related to the device but unlikely related to the procedure.Initial imp.Date is unknown, it is known it was in 2019.
Additional Manufacturer Narrative
Durning the investigation the event was found to be a revision of a competitors device and the inital implant of exactech devices.This event was determined to be a non-complaint as there is no evidence that the device failed to meet its specifications or to perform as intended.Please disregard.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision was based on review of all available information, there is no indication that there is a device related problem, there is no allegation against the device.The most likely cause of the reported event is related to the patient¿s underlying condition.Section (d10).Concomitant devices: - tibial insert (cat# 02-022-44-3009); - tibial tray (cat# 02-022-45-3030); - tibial stem extension (cat# 204-70-00); - patellar (cat# 200-02-32).Section(s): no information has been provided: a2, a5, b6, d4 (serial number and exp date), and h4.The following section(s) have additional info: g7, h1, h2, h3, and h7.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CC FEMORAL SIZE 3, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9775033
• Report Number: 1038671-2020-00234
• Device Sequence Number: 16485766
• Product Code: JWH
• UDI-Device Identifier: 10885862265661
• UDI-Public: 10885862265661
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2020

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 Model Number: 02-010-06-0230
• Device Catalogue Number: 02-010-06-0230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 02/11/2020; 09/10/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 08/26/2020; 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 87