MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC TIBIA FIN TRAY CEM SZ 4F/4T

Model Number	02-012-39-4040
Health Effect - Clinical Codes	No Information (3190); No Code Available (3191)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.Concomitant medical device(s): 3 peg patella, 35mm (cn: 200-02-35; sn: (b)(4)).Optetrak logic ps modular tibial insert size 4, 11mm (cn: 02-012-35-4011; sn: unk).Optetrak logic ps femoral component, cemented, left, size 4 (cn: 02-010-01-0240; sn: (b)(4)).Initial reporter's occupation: attorney.
Event or Problem Description
Index surgery: (b)(6) 2011.Pending revision of the left knee - reason unknown.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the pending 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, 35mm (cn: 200-02-35; sn: (b)(6)) -optetrak logic ps modular tibial insert size 4, 11mm (cn: 02-012-35-4011; sn: unk) -optetrak logic ps femoral component, cemented, left, size 4 (cn: 02-010-01-0240; sn: (b)(6)) no information provided in the following section(s): a4, a5, and d7.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC TIBIA FIN TRAY CEM SZ 4F/4T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9069786
• Report Number: 1038671-2019-00453
• Device Sequence Number: 16776481
• Product Code: JWH
• UDI-Device Identifier: 10885862002730
• UDI-Public: 10885862002730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K932776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: 08/16/2016
• Device Model Number: 02-012-39-4040
• Device Catalogue Number: 02-012-39-4040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 03/31/2020
• 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: 66 YR