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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 Mechanical Problem (1384)
Patient Problem Limited Mobility Of The Implanted Joint (2671)
Event Date 06/01/2014
Event Type  Injury  
Event Description
The patient has not achieved the desired amount of flexion and extension.Revision surgery is planned to determine the cause of limited range of motion.Poly inserts will be exchanged during the procedure.
 
Manufacturer Narrative
The patient has not achieved the desired amount of flexion and extension.Revision surgery is planned to determine the cause of limited range of motion.Poly inserts will be exchanged during the procedure.Review of the device history record indicates that the device was manufactured to specification.
 
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Brand Name
IUNI G2
Type of Device
UNICONDYLAR KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS
28 crosby drive
bedford MA 01730
Manufacturer Contact
amita shah
28 crosby drive
bedford, MA 01730
7813459164
MDR Report Key3911602
MDR Text Key4489899
Report Number3004153240-2014-00077
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111916
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 06/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/01/2014
Device Catalogue NumberM57220600220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/04/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
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 Age52 YR
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