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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 TPS111111101
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the procedure for the debridement of soft tissue was performed for a patient with an itotal knee replacement due to a patella crepitation.Review of the device history record indicates that the device was manufactured to specification.
 
Event or Problem Description
It was reported that the procedure for the debridement of soft tissue was performed for a patient with an itotal knee replacement due to a patella crepitation.
 
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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 Key7600354
Report Number3004153240-2018-00141
Device Sequence Number11160453
Product Code JWH
UDI-Device IdentifierM572TPS1111111011
UDI-Public+M572TPS1111111011
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K142404
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/14/2018
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 Date04/30/2016
Device Model NumberTPS111111101
Device Catalogue NumberTPS-111-1111
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/17/2018
Initial Report FDA Received Date06/14/2018
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 Age55 YR
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