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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
Catalog Number TPS-111-1111
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/01/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the patient has an infection.A revision surgery is planned to exchange the poly insert.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 an infection.A revision surgery is planned to exchange the poly 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 Key6847884
Report Number3004153240-2017-00190
Device Sequence Number16154402
Product Code JWH
UDI-Device IdentifierM572TPS1111111011
UDI-Public+M572TPS1111111011/
Combination Product (Y/N)N
Initial Reporter StateMD
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) 09/07/2017
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 Date05/31/2016
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 08/10/2017
Initial Report FDA Received Date09/07/2017
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 Age75 YR
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