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

Model Number	02-012-41-4040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.Concomitant medical products: tibial insert (cn: 02-012-48-4009/sn: (b)(4).
Event or Problem Description
Patient had pain and subsequent revision of the tibial tray.The device will not be returned for evaluation as we are not able to take from hospital.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted in the revision as reported, the initial right knee tka was implanted for patient was on (b)(6) 2015.This 63 y/o male patient who is slightly larger than average size complained of pain.And subsequent revision of the tibial tray on 10/01/2019.The device will not be returned for evaluation as we are not able to take from hospital.All available information received at this time.Upon further review, the pain may have been a result of patient conditions; however, this could not confirm because additional info was not available and the devices were not returned.(d11) concomitant device(s): tibial insert (cn: 02-012-48-4009 / sn: (b)(6).No information provided in the following section(s): a2, a3, a4, a5, b3, b5, b6, b7, and d6.The following section(s) have additional info: b3, g4, g7, h1, h2, h3, h6 and h7.
Event or Problem Description
As reported, the patient was initially implanted on (b)(6) 2015.The patient complained of pain and the tibial tray was revised on (b)(6) 2019.The device will not be returned for evaluation due to hospital policy.Upon further review, the pain may have been a result of patient conditions; however, this could not confirm because additional info was not available and the devices were not returned.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9208723
• Report Number: 1038671-2019-00530
• Device Sequence Number: 447301
• Product Code: JWH
• UDI-Device Identifier: 10885862003232
• UDI-Public: 10885862003232
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 11/22/2020
• Device Model Number: 02-012-41-4040
• Device Catalogue Number: 02-012-41-4040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 05/13/2020
• 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