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 REPAIR 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 REPAIR SYSTEM Back to Search Results
Model Number TPS-101-1112
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 06/19/2022
Event Type  Injury  
Manufacturer Narrative
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is laxity.Primary surgery occurred on (b)(6) 2022.Revision surgery is planned for (b)(6) 2022.The device history record was reviewed and the device was manufactured per the specifications.All sterilisation requirements were met.
 
Event Description
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is laxity.Primary surgery occurred on (b)(6) 2022.Revision surgery is planned for (b)(6) 2022.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ITOTAL IDENTITY PS
Type of Device
TOTAL KNEE REPAIR 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
kara johnson
600 technology park drive
billerica, MA 01821
MDR Report Key15061456
MDR Text Key296210540
Report Number3004153240-2022-00117
Device Sequence Number1
Product Code JWH
UDI-Device IdentifierM572TCR1011112011
UDI-PublicM572TCR1011112011
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K210252
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTPS-101-1112
Device Catalogue NumberTCR1011112
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age60 YR
-
-