MAUDE Adverse Event Report: EXACTECH, INC. OPTAETRAK LOGIC; LOGIC TIBIAL FIT TRAY CEM SZ 3F / 4T

Model Number	02-012-45-3040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation: concomitant device(s): 3 peg patella, 32mm (cn: 200-02-32; sn: (b)(4)).Optetrak logic ps femoral component, cemented, left, size 3 (cn: 02-010-01-0230; sn: (b)(4)).Optetrak logic ps modular tibial insert, size 3, 9mm (cn: 02-012-35-3009; sn:(b)(4)).Initial reporter's occupation: attorney.
Event or Problem Description
Index surgery: (b)(6) 2014.Pending revision of the left knee - reason not reported.
Additional Manufacturer Narrative
The evaluation noted that the reason for the revision was not provided but was likely the result of wear, loosening, infection, fracture, instability, or patient related factors.(d11) concomitant device(s): 3 peg patella, 32mm (cn: (b)(4),sn: (b)(6).Optetrak logic ps femoral component, cemented, left, size 3 (cn: (b)(4),sn: (b)(6).Optetrak logic ps modular tibial insert, size 3, 9mm (cn: (b)(4),sn: (b)(6).(e3) initial reporter's occupation: attorney.

• Brand Name: OPTAETRAK LOGIC
• Common Device Name: LOGIC TIBIAL FIT TRAY CEM SZ 3F / 4T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9069828
• Report Number: 1038671-2019-00455
• Device Sequence Number: 16769945
• Product Code: JWH
• UDI-Device Identifier: 10885862003973
• UDI-Public: 10885862003973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101981
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 04/16/2024
• Device Model Number: 02-012-45-3040
• Device Catalogue Number: 02-012-45-3040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 04/01/2020
• 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: Other
• Patient Age: 65 YR