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U.S. Department of Health and Human Services

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

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CONFORMIS, INC. IUNI G2 UNICONDYLAR KNEE REPLACEMENT SYSTEM Back to Search Results
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.

 
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Brand NameIUNI G2
Type of DeviceUNICONDYLAR 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 Key10317920
MDR Text Key200190225
Report Number3004153240-2020-00128
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK132640
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
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 Received07/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberM5722INT0600210
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/24/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/23/2020 Patient Sequence Number: 1
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