MAUDE Adverse Event Report: EXACTECH, INC. OPTETRAK PS TIBIAL INSERT, SIZE 2, 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED

Model Number OPTETRAK PS TIBIAL INSERT, SIZE 2, 11MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 01/08/2020

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported by the legal brief, on (b)(6) 2008, patient underwent a left total knee replacement surgery and was implanted with an optetrak device, including an optetrak ps tibial insert, size 2, 11mm made of polyethylene.Patient underwent revision surgery of her left knee on (b)(6) 2020.No additional information available.

Manufacturer Narrative

(h3) as reported by the legal brief, on (b)(6) 2008, patient underwent a left total knee replacement surgery and was implanted with an optetrak device, including an optetrak ps tibial insert, size 2, 11mm made of polyethylene.Patient underwent revision surgery of her left knee on (b)(6) 2020.No additional information available.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: OPTETRAK PS TIBIAL INSERT, SIZE 2, 11MM
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16264412
• MDR Text Key: 308376070
• Report Number: 1038671-2023-00077
• 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
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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
• Device Model Number: OPTETRAK PS TIBIAL INSERT, SIZE 2, 11MM
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/13/2023
• 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