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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL PS; TOTAL KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. ITOTAL PS; TOTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Model Number TPS121111102
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 03/01/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the patient had laxity of an unknown cause.Revision surgery occurred where the surgeon exchanged the patient's 6mm poly insert for an 8mm insert.Review of the device history record indicates that the device was manufactured to specification.
 
Event or Problem Description
It was reported that the patient had laxity of an unknown cause.Revision surgery occurred where the surgeon exchanged the patient's 6mm poly insert for an 8mm insert.
 
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Brand Name
ITOTAL PS
Common Device Name
TOTAL KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
MDR Report Key11593082
Report Number3004153240-2021-00045
Device Sequence Number16997938
Product Code JWH
UDI-Device IdentifierM572TPS1211111021
UDI-Public+M572TPS1211111021
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
PMA/510(K) Number
K161668
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) 03/30/2021
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 NumberTPS121111102
Device Catalogue NumberTPS-121-1111
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/12/2021
Initial Report FDA Received Date03/30/2021
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 Age62 YR
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