MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC CR FEMORAL CEM, RIGHT, SZ 4

Model Number	02-010-03-0340
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: optetrak tibial tray (cn: unknown; sn: unknown); optetrak liner (cn: unknown; sn: unknown).Pending engineering evaluation.
Event or Problem Description
Revision of knee components: reason not reported.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported was not provided but was likely the result of wear, loosening, infection, fracture, instability, or patient related factors.(d11) concomitant device(s): optetrak tibial tray (cn: unknown; sn: unknown).Optetrak liner (cn: unknown; sn: unknown).

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC CR FEMORAL CEM, RIGHT, SZ 4
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9161666
• Report Number: 1038671-2019-00485
• Device Sequence Number: 19481009
• Product Code: JWH
• UDI-Device Identifier: 10885862158130
• UDI-Public: 10885862158130
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 02-010-03-0340
• Device Catalogue Number: 02-010-03-0340
• Device Lot Number: 06760676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 04/23/2020
• 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