MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM

Catalog Number M5722INT0600210

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Toxicity (2333); No Code Available (3191)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient had metal abrasion disease, metallosis, with increased abrasion with metallotic synovialitis.The patient also had loosening of the prosthesis and polyethylene wear after 6 years.Review of the device history record indicates that the device was manufactured to specification.All sterilization requirements were met.

Event Description

It was reported that the patient had metal abrasion disease, metallosis, with increased abrasion with metallotic synovialitis.The patient also had loosening of the prosthesis and polyethylene wear after 6 years.

• Brand Name: IUNI G2
• Type of Device: UNICONDYLAR KNEE REPLACEMENT SYSTEM
• Manufacturer (Section D): CONFORMIS, INC.; 600 technology park drive; billerica, ma
• Manufacturer (Section G): CONFORMIS, INC.; 600 research drive; wilmington, ma
• Manufacturer Contact: emmanuel nyakako ; 600 technology park drive; billerica, ma ; 3459164
• MDR Report Key: 10317920
• MDR Text Key: 200190225
• Report Number: 3004153240-2020-00128
• Device Sequence Number: 1
• Product Code: HSX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132640
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M5722INT0600210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2013
• 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 Age: 54 YR