MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CC FEMORAL SIZE 4, RIGHT

Model Number	02-010-06-0340
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant devices: tibial insert cn: 02-012-65-4015, sn: unk); tibial tray (cn: 02-012-45-4030, sn: unk).
Event or Problem Description
As reported by the exactech knee replacement study, approximately 3.5 years postop implantation, this (b)(6) y/o male patient, who weighs (b)(6) lbs., was revised due to ¿failed right tka, aseptic loosening¿.No other information available.Treatment is noted as resolved.The event is definitely related to the device and unlikely related to the procedure.This event report was received through clinical data collection activities.
Additional Manufacturer Narrative
It has been determined during the investigation that the patient has been deleted from the study database.This was reported in error.This case can close as a non-complaint.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CC FEMORAL SIZE 4, RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9775498
• Report Number: 1038671-2020-00236
• Device Sequence Number: 1431886
• Product Code: JWH
• UDI-Device Identifier: 10885862265722
• UDI-Public: 10885862265722
• 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: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02-010-06-0340
• Device Catalogue Number: 02-010-06-0340
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/12/2020
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR