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

Catalog Number	02-012-35-3509
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	10/29/2015
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 a patient had a right knee arthroplasty on (b)(6) 2015, with no revision surgery reported.There was no other patient/medical information provided.No x-rays or images were provided.There is no other information available.
Additional Manufacturer Narrative
D1: corrected the following: brand name.D4: corrected the following: catalog number, expiration date, serial number, unique identifier (udi) #.G3/4: corrected the following: pma/510(k)number.H4: corrected the following: device manufacture date.H6: corrected the following: health effect - clinical code, impact code, component code, type of investigation, investigation findings, investigation conclusions.The reason for the reported event cannot be confirmed from the information provided but may be due to prosthesis wear and/or inclusion of the polyethylene in the packaging recall.Potential contributions of user and patient-related considerations to the event could not be assessed as the devices were not available for evaluation and images, radiographs, and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653
• MDR Report Key: 19510880
• Report Number: 1038671-2024-01889
• Device Sequence Number: 3455742
• Product Code: JWH
• UDI-Device Identifier: 10885862001849
• UDI-Public: 10885862001849
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K093360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 11/19/2024

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: 08/26/2023
• Device Catalogue Number: 02-012-35-3509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• 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