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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY CR; TOTAL KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. ITOTAL IDENTITY CR; TOTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Model Number TCR101111201
Device Problems Tear, Rip or Hole in Device Packaging (2385); Contamination /Decontamination Problem (2895)
Patient Problem Insufficient Information (4580)
Event Date 11/19/2021
Event Type  Injury  
Manufacturer Narrative
It was reported that at the time of opening the implants it was discovered the tibia was contaminated and the pouch was punctured through both sterile packages.There was a major delay of 35 minutes due to this issue.Review of the device history record indicates that the device was manufactured and packaged to specification.All sterilisation requirements were met.
 
Event Description
It was reported that at the time of opening the implants it was discovered the tibia was contaminated and the pouch was punctured through both sterile packages.There was a major delay of 35 minutes due to this issue.
 
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Brand Name
ITOTAL IDENTITY CR
Type of Device
TOTAL KNEE REPLACEMENT 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 Key13041059
MDR Text Key282485578
Report Number3004153240-2021-00229
Device Sequence Number1
Product Code JWH
UDI-Device IdentifierM572TCR1011112011
UDI-PublicM572TCR1011112011
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K210809
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 12/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTCR101111201
Device Catalogue NumberTCR-101-1112
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/29/2021
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;
Patient Age59 YR
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