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

Model Number OPTETRAK KNEE

Device Problem Peeled/Delaminated (1454)

Patient Problem Osteomyelitis (4533)

Event Date 12/30/2021

Event Type  Injury  

Manufacturer Narrative

No device return anticipated.Concomitants: 02-012-45-1515 - lgc tibial fit tray cem sz 1.5f / 1.5t; 02-010-03-0215 - logic cr femoral cem, left sz 1.5; 200-02-29 - three peg patella 29mm.Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

It was reported via a legal filing that a female patient underwent revision surgery approximately 3 years 8 months post her initial left knee tka.Initially implanted with an optetrak device, including a size 1.5, 13 mm optetrak logic tibial inserts made of polyethylene.The plaintiff was diagnosed with failed total arthroplasty with early polyethylene failure.Before the revision surgery, she was also diagnosed with osteomyelitis in her knee due to the breakdown of the polyethylene.During the revision surgery, the plaintiff's surgeon stated, "we were able to lever the polyethylene plastic with a small osteotome and after this was retrieved, we then inspected the plastic, noted to have pitting and delamination of the medial aspect of the tibial polyethylene.Otherwise, the polyethylene looked to be in good condition laterally.".

Manufacturer Narrative

This event was already reported under 1038671-2022-00722.This is a duplicate report.

• Brand Name: OPTETRAK KNEE
• 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: 15020156
• MDR Text Key: 295950970
• Report Number: 1038671-2022-00790
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10885862144423
• UDI-Public: 10885862144423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

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 Expiration Date: 08/11/2019
• Device Model Number: OPTETRAK KNEE
• Device Catalogue Number: 02-012-49-1513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2011
• 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