MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK; NMC FEMORAL SZ 3

Model Number	210-01-03
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.Concomitant medical device(s): cc tibial insert sz 3, 30mm (cn: 208-23-30, sn: (b)(4)).Logic stem ext 14mm x 25mm (cn: 02-012-60-1425, sn: (b)(4)).Three peg patella 35mm (cn: 200-02-35, sn: (b)(4)).Logic tibial fit tray cem sz 3f / 3t(cn: 02-012-45-3030, sn: (b)(4)).
Event or Problem Description
Index surgery: (b)(6) 2018.The patient is suffering from an infection.The implants were explanted.The original surgery was performed in (b)(6) 2018.There was no delay to the surgery.The rep was present at the time of the surgery.The devices will not be returned for evaluation.
Event or Problem Description
As reported, the 60 y/o patient was suffering from an infection.A wash-out" procedure was done approximately 6 mos postop however the infection persisted.The implants were explanted approximately 10 months postoperatively.The devices will not be returned for evaluation per hospital policy.The patient¿s weight is 211 lbs.No other information is available at this time.Index surgery: (b)(6) 2018.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.
Additional Manufacturer Narrative
The evaluation noted that as reported, the 60 y/o patient was suffering from an infection.The implants were explanted approximately 10 months postoperatively.The devices will not be returned for evaluation per hospital policy.The patient¿s weight is 211 lbs.No other information is available at this time.Index surgery: (b)(6) 2018.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.Reference: 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.(d11) concomitant device(s): cc tibial insert sz 3, 30mm (cn: (b)(4),sn: (b)(6).Logic stem ext 14mm x 25mm (cn: (b)(4),sn: (b)(6).Three peg patella 35mm (cn: (b)(4),sn: (b)(6).Logic tibial fit tray cem sz 3f / 3t (cn: (b)(4),sn: (b)(6).

• Brand Name: OPTETRAK
• Common Device Name: NMC FEMORAL SZ 3
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9125823
• Report Number: 1038671-2019-00471
• Device Sequence Number: 11673185
• Product Code: JWH
• UDI-Device Identifier: 10885862057402
• UDI-Public: 10885862057402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• 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: 02/20/2023
• Device Model Number: 210-01-03
• Device Catalogue Number: 210-01-03
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 96