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

Catalog Number	02-012-65-2015
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11.Pending investigation.There is no other information provided.
Event or Problem Description
It was reported via legal documentation that the patient was implanted with an optetrak logic device on the left knee, with no revision surgery reported.It is stated the patient has suffered the following injuries and complications: pain, stiffness, discomfort, and weakness which in turn negatively affected plaintiff's mobility and quality of life.There was no other patient/medical information provided.No x-rays or images were provided.There is no other information available.
Additional Manufacturer Narrative
D10 concomitant devices: 02-012-61-6000 - tru offset stem ext coupler, 6mm 4996577 02-010-66-1002 - metaphyseal femoral cone, small, h42mm 5336474 02-012-64-1480 - tru fluted stm ext 14mm x 80mm blast 5892677 02-010-06-0220 - tru cc femoral size 2 left 6061618 h4: corrected.
Additional Manufacturer Narrative
D: added product information for medical suspect device.The reason the reported event cannot be confirmed from the information provided, but may have been due to prosthesis wear.Potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not available for evaluation and no images, radiographs, or relevant clinical information was provided.

• Brand Name: OPTETRAK LOGIC TIBIAL INSERT
• 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 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19559883
• Report Number: 1038671-2024-01962
• Device Sequence Number: 6730732
• Product Code: JWH
• UDI-Device Identifier: 10885862613325
• UDI-Public: 10885862613325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2024

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 Expiration Date: 06/13/2024
• Device Catalogue Number: 02-012-65-2015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 10/02/2024; 10/02/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 10/04/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown