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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM
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CONFORMIS IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number M57220600220
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 06/01/2014
Event Type  Injury  
Event Description
Revision surgery occured for patient with a unicondylar knee implant.
 
Manufacturer Narrative
Revision surgery occurred for patient with a unicondylar knee implant.Review fo the device history record indicates that the device was manufactured to specification.The tibial implants were returned and investigation is in progress.Evaluation of returned implants will be documented in a supplemental report.
 
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Brand Name
IUNI G2
Type of Device
UNICONDYLAR KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS
28 crosby dr.
bedford MA 01730
Manufacturer Contact
karina snow
28 crosby dr.
bedford, MA 01730
7816459164
MDR Report Key3955160
MDR Text Key15107402
Report Number3004153240-2014-00093
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/01/2012
Device Catalogue NumberM57220600220
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/25/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/25/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2011
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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