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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL G2; TOTAL KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. ITOTAL G2; TOTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Model Number TCR121111102
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the patient has developed laxity over time and requires poly inserts of a different thickness.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 developed laxity over time and requires poly inserts of a different thickness.Revision surgery is planned to exchange the poly inserts.
 
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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 Key12110208
Report Number3004153240-2021-00098
Device Sequence Number11635446
Product Code JWH
UDI-Device IdentifierM572TCR1211111021
UDI-Public+M572TCR1211111021
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K180906
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) 07/02/2021
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 NumberTCR121111102
Device Catalogue NumberTCR-121-1111
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/03/2021
Initial Report FDA Received Date07/02/2021
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 Age73 YR
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