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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
Catalog Number TCR-121-SPEC
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/01/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that a procedure is planned to perform soft tissue releases to loosen the knee and to exchange the poly inserts.Review of the device history record indicates that the device was manufactured to specification.
 
Event or Problem Description
It was reported that a procedure is planned to perform soft tissue releases to loosen the knee and 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 Key6600462
Report Number3004153240-2017-00117
Device Sequence Number16344100
Product Code JWH
UDI-Device IdentifierM572TCR121SPEC021
UDI-Public+M572TCR121SPEC021
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K161366
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/31/2017
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 Physician
Device Expiration Date07/31/2017
Device Catalogue NumberTCR-121-SPEC
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/03/2017
Initial Report FDA Received Date05/31/2017
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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