MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM

Model Number	02-012-44-3015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending engineering evaluation.No information provided in the following section(s): sex, weight, and relevant tests/laboratory data.
Event or Problem Description
The patient has an infection and the insert was swapped with a new one and the joint was washed out.Patient was stable leaving the operating room.There was no delay to the surgery.The rep was present at the time of the surgery.The device will not be returned for evaluation.
Additional Manufacturer Narrative
The evaluation noted that as reported, this 73 y/o male patient was initially implanted on (b)(6) 2018 with a total knee joint and experienced an infection approximately 11 months postop.The insert only was swapped with a new one and the joint was washed out.Patient was stable leaving the or.There was no delay to the surgery.The rep was present at the time of the surgery.The device will not be returned for evaluation per hospital policy.Any ¿surgical site¿ infection noted in a patient that is greater than 3 months postop from a total joint surgical procedure is highly unlikely to be related to the surgical procedure for placement of the total joint or the device itself.(ref 1).It is noted that surgical intervention or revision along with infection is a known risk in any total joint surgery and may result in revision.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision, cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.1.Acute infection in total knee arthroplasty: diagnosis and treatment juan carlos martínez-pastor,* francisco maculé-beneyto, and santiago suso-vergara author information article notes copyright and license information disclaimer open orthop j.2013; 7: 197¿204.Published online 2013 jun 14.
Event or Problem Description
As reported, this 73 y/o male patient was initially implanted on (b)(6) 2018 with a total knee joint and experienced an infection approximately 11 months postop.The insert only was swapped with a new one and the joint was washed out.Patient was stable leaving the or.There was no delay to the surgery.The rep was present at the time of the surgery.The device will not be returned for evaluation per hospital policy.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9125739
• Report Number: 1038671-2019-00470
• Device Sequence Number: 14107151
• Product Code: JWH
• UDI-Device Identifier: 10885862173584
• UDI-Public: 10885862173584
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 06/24/2022
• Device Model Number: 02-012-44-3015
• Device Catalogue Number: 02-012-44-3015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 03/24/2020
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 59