MAUDE Adverse Event Report: THINK SURGICAL TSOLUTION ONE TOTAL KNEE APPLICATION; TCAT

Model Number 108300

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

Patient Problem Joint Laxity (4526)

Event Date 07/25/2022

Event Type  Injury  

Manufacturer Narrative

The product instructions for use (ifu) under "contraindication", section lists: "a pathological skeletal condition that would impair the ability of the bone to withstand the stress of femoral preparation and prosthesis placement or tibial preparation and prosthesis placement (e.G., severe osteoporosis, paget's disease renal osteodystrophy)." the patient was identified with very hypoplastic femur/tibia.No device malfunction has been reported.From the information provided by the physician and hospital, think surgical is unable to determine the cause of the event.The surgeon confirmed his clinical opinion that this is not caused by the think robotic procedure.

Event Description

It was reported that surgeon had to complete revision due to the aseptic loosening four years after surgery.Right robotic tka was done as part of the ide in 2018.Patient was doing fine but had 2 falls onto the knee and then was non weightbearing on the other leg for three months so put a lot of pressure on this knee.Intraop, the cement on the femur seemed to have debonded from the femoral implant.

• Brand Name: TSOLUTION ONE TOTAL KNEE APPLICATION
• Type of Device: TCAT
• Manufacturer (Section D): THINK SURGICAL; 47201 lakeview blvd.; fremont 94538
• Manufacturer (Section G): THINK SURGICAL; 47201 lakeview blvd; fremont 94538
• Manufacturer Contact: meliha mulalic ; 47201 lakeview blvd; fremont 94538 ; 5102492337
• MDR Report Key: 15288387
• MDR Text Key: 298558798
• Report Number: 3000719653-2022-00005
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 108300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male