Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL G2; TOTAL KNEE REPLACEMENT SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONFORMIS, INC. ITOTAL G2; TOTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number TCR-111-SPEC
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the patient has an infection.A revision surgery is planned to exchange the poly inserts.Review of the device history record indicates that the device was manufactured to specification.All sterilization requirements were met.
 
Event or Problem Description
It was reported that the patient has an infection.A revision surgery is planned to exchange the poly inserts.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ITOTAL G2
Common Device Name
TOTAL KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
MDR Report Key7657862
Report Number3004153240-2018-00157
Device Sequence Number11391765
Product Code JWH
UDI-Device IdentifierM572TCR111SPEC021
UDI-Public+M572TCR111SPEC021
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K161366
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/03/2018
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
Operator of Device Physician
Device Expiration Date08/31/2018
Device Catalogue NumberTCR-111-SPEC
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/25/2018
Initial Report FDA Received Date07/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age56 YR
-
-