MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CC FEMORAL SIZE 5, LEFT

Model Number	02-010-06-0250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during an initial tka, this (b)(6) y/o male patient¿s left femur fractured during impacting the femur trial.There was no delay and the patient was last known to be in stable condition following the event.There is no device to be returned.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the revision reported based upon review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the bone fracture cannot be conclusively determined; however, it is most likely is related to the patient¿s underlying condition.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CC FEMORAL SIZE 5, LEFT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10560595
• Report Number: 1038671-2020-00541
• Device Sequence Number: 2822418
• Product Code: JWH
• UDI-Device Identifier: 10885862265685
• UDI-Public: 10885862265685
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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 Expiration Date: 08/12/2023
• Device Model Number: 02-010-06-0250
• Device Catalogue Number: 02-010-06-0250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2020
• Supplement Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR