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 IDENTITY PS; 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 IDENTITY PS; TOTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Model Number TPS101111201
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/23/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is infection.Primary surgery occurred on (b)(6) 2020.Revision surgery date is unknown.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.
 
Event or Problem Description
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is infection.Primary surgery occurred on (b)(6) 2020.Revision surgery date is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ITOTAL IDENTITY PS
Common Device Name
TOTAL KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
MDR Report Key12685268
Report Number3004153240-2021-00179
Device Sequence Number4233247
Product Code JWH
UDI-Device IdentifierM572TPS1011112011
UDI-PublicM572TPS1011112011
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
PMA/510(K) Number
K201023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/22/2021
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 Health Professional
Device Model NumberTPS101111201
Device Catalogue NumberTPS-101-1112
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/23/2021
Initial Report FDA Received Date10/22/2021
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 Age70 YR
-
-