MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK LOGIC; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	02-012-47-6015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant: (b)(6), 200-02-41 - three peg patella 41mm.(b)(6), 02-010-04-0260 - logic cr femoral por, left, sz 6.(b)(6), 02-012-45-6060 - lgc tibial fit tray cem sz 6f / 6t.(b)(6), 201-78-15 - holding pin mini sharp point 4 pk.(b)(6), 521-78-23 - threaded pin size 2.3 collared.(b)(6), 521-78-23 - threaded pin size 2.3 collared.(b)(6), 521-78-23 - threaded pin size 2.3 collared.(b)(6), a10012 - gps implant kit v2.
Event or Problem Description
Approximately a month after a left knee replacement, the patient was revised due to infection.The patient was washed out.The liner was exchanged.The event is not related to a breakage of a device.The event did not lead to a surgical delay/prolongation.Patient was last known to be in stable condition following the event.Unable to obtain device images or x-rays.Product not returning: disposed.
Additional Manufacturer Narrative
According to the information provided, the patient underwent a total knee replacement surgery on (b)(6) 2018.Approximately 5 years and 8 months later, on (b)(6) 2024, the patient was revised due to prosthesis wear.At this time, the tibial insert and patella component were revised.This first revision is captured in case (b)(4).Approximately 1 month following the first revision, on (b)(6) 2024, the patient underwent a second revision surgery ¿due to infection¿ and a wash out was performed.Only the insert was replaced.The device was not returned for evaluation, and no images or radiographs were provided.A review of the sterile certificates for the tibial insert and the patella component was performed.All lots were accepted to the requirements.The reason for the reported revision due to infection cannot be conclusively determined; however, it may be related to an underlying patient condition.

• Brand Name: OPTETRAK LOGIC
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 court; gainesville 32653 ; 3525541928
• MDR Report Key: 19651097
• Report Number: 1038671-2024-02243
• Device Sequence Number: 18024201
• Product Code: JWH
• UDI-Device Identifier: 10885862174673
• UDI-Public: 10885862174673
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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 Catalogue Number: 02-012-47-6015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male