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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL IDENTITY CR; TOTAL KNEE REPAIR SYSTEM

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CONFORMIS, INC. ITOTAL IDENTITY CR; TOTAL KNEE REPAIR SYSTEM Back to Search Results
Model Number TCR101111201
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Arthritis (1723); Pain (1994)
Event Date 01/03/2022
Event Type  Injury  
Manufacturer Narrative
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is midflexion instability and development of patellofemoral arthritis and pain.Primary surgery occurred on (b)(6) 2021.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 Description
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is midflexion instability and development of patellofemoral arthritis and pain.Primary surgery occurred on (b)(6) 2021.Revision surgery date is unknown.
 
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Brand Name
ITOTAL IDENTITY CR
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 Key13429525
MDR Text Key284961516
Report Number3004153240-2022-00012
Device Sequence Number1
Product Code JWH
UDI-Device IdentifierM572TCR1011112011
UDI-PublicM572TCR1011112011
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203447
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 02/02/2022
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
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
Initial Date Manufacturer Received 01/03/2022
Initial Date FDA Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/05/2020
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 Age70 YR
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