MAUDE Adverse Event Report: EXACTECH, INC. KNEE COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 11/17/2021

Event Type  Injury  

Event Description

As reported by legal, this patient had an initial left tka on (b)(6) 2014.The patient was revised on (b)(6) 2021.The surgeon found that the recalled optetrak polyethylene failed.No other patient information/medical history reported.The original report stated that the right side was revised.This was determined to be a typographical error and was possibly intended to say the left knee was revised, as we only show the initial left knee implant and no revision right knee surgeries.

Manufacturer Narrative

Pending investigation.

Manufacturer Narrative

H3: based on review of all available information, there is no evidence to suggest that the reported event is related to any design issues.The cause of the subsequent revision cannot be conclusively determined, insufficient information.These devices are used for treatment not diagnosis.

• Brand Name: KNEE COMPONENT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 16244852
• MDR Text Key: 308144266
• Report Number: 1038671-2023-00072
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/05/2023
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female