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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 M5722INT0600220
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
A revision surgery is planned to exchange the poly insert.Reason for revision is unknown at this time.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
A revision surgery is planned to exchange the poly insert.Reason for revision is unknown at this time.
 
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Brand Name
IUNI G2
Type of Device
UNICONDYLAR KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
Manufacturer Contact
karina snow
600 technology park drive
billerica, MA 01821
7813459195
MDR Report Key6529124
MDR Text Key73899808
Report Number3004153240-2017-00089
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K133256
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/28/2017
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
Device Operator Physician
Device Expiration Date06/30/2014
Device Catalogue NumberM5722INT0600220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/31/2017
Initial Date FDA Received04/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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