MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL G2; TOTAL KNEE REPLACEMENT SYSTEM

Catalog Number M5725INT060XE20

Device Problems Unsealed Device Packaging (1444); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the pouch containing the femoral component was not properly sealed at the bottom resulting in the femoral implant falling out of the bag and onto the floor.The implant was washed and the case was completed successfully.Review of the device history record indicates that the device was manufactured to specification.Upon investigating, the most likely root cause for the faulty pouch seal can be attributed to a malfunctioning pouch sealing machine.

Event Description

It was reported that the pouch containing the femoral component was not properly sealed at the bottom resulting in the femoral implant falling out of the bag and onto the floor.The implant was washed and the case was completed successfully.

• Brand Name: ITOTAL G2
• Type of Device: TOTAL KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica MA 01821
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington MA 01887
• Manufacturer Contact: paul smolenski ; 600 technology park drive; billerica, MA 01821 ; 7813459161
• MDR Report Key: 9056462
• MDR Text Key: 163126890
• Report Number: 3004153240-2019-00220
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K180906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M5725INT060XE20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2019
• Initial Date FDA Received: 09/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2019
• 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 Age: 70 YR