MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER

Model Number	OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 11MM
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/25/2008
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via legal documentation the patient had a right knee replacement on (b)(6) 2007.Approximately 10 months after the initial procedure the patient had a right knee revision on (b)(6) 2008.There is no other patient demographic or medical history available.There is no device return.There are no photos or other images of the device provided.No additional information is available.Revision op report on (b)(6) 2008.Diagnosis: painful right replacement the knee was aspirated and 20cc of yellowish, red knee fluid.No infection.The tibia appeared to be a little too large.There was a little overhang in the front and at the anteromedial corner also an overhang on the lateral aspect as well.The tibial base plate appeared to be just slightly internally rotated.A trial reduction was done.The sterile dressings were applied.There were no complications.The patient was transferred to the recovery room in stable condition.
Additional Manufacturer Narrative
Pending investigation.
Additional Manufacturer Narrative
H10.Additional information ¿ a3, g2, h6 medical device problem code, h8 h3.Investigation results - the cause of the patient¿s pain and subsequent revision as related to the devices cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition as associated with the interaction between the implanted device and the patient due to patient illness, unique anatomy, or other condition that impacts the performance of the device.The implant size appears to be the most likely cause of the patient's pain.There is no indication from the revision operative report that the knee implants malfunctioned or had wear.The rotation of the implant affects how the implants function, it may not be able to properly function as intended as the knee flexes and extends.The tibial insert is an important factor on the overall balance of the knee and how it feels after replacement.These devices are used for treatment not diagnosis.There is no additional information available.

• Brand Name: OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17652362
• Report Number: 1038671-2023-02102
• Device Sequence Number: 15296536
• Product Code: JWH
• UDI-Device Identifier: 10885862064004
• UDI-Public: 10885862064004
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K033883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2008
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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: 10/02/2012
• Device Model Number: OPTETRAK HI-FLEX TIBIAL INSERT SZ 3 11MM
• Device Catalogue Number: 244-23-11
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 08/30/2023
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2007
• 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: Female