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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number UKA-111-1111
Health Effect - Clinical Code Pain (1994)
Date of Event 01/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The patient reported that he is having an issues with his iuni replacement following the primary surgery.The patient reported that he is experiencing pain.The surgeries to remove plica occurred.Review of the device history record indicates the device was manufactured to specification.
 
Event or Problem Description
The patient reported that he is having an issues with his iuni replacement following the primary surgery.The patient reported that he is experiencing pain.The surgeries to remove plica occurred.
 
Additional Manufacturer Narrative
Corrected data: the 510k number was corrected.
 
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Brand Name
IUNI G2
Common Device Name
UNICONDYLAR KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
MDR Report Key7214753
Report Number3004153240-2018-00015
Device Sequence Number18865858
Product Code HSX
UDI-Device IdentifierM572UKA1111111031
UDI-Public+M572UKA1111111031
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K133256
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial,Followup
Report Date (Section B) 02/26/2018
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 Date08/31/2016
Device Catalogue NumberUKA-111-1111
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/10/2018
Supplement Date Received by Manufacturer01/10/2018
Initial Report FDA Received Date01/24/2018
Supplement Report FDA Received Date02/26/2018
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 Age50 YR
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