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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 M57220600210
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 11/01/2014
Event Type  Injury  
Event Description
Patient sustained a proximal tibial fracture at one day post-op.Surgery occurred to plate the tibia.It was reported that the implants are stable but the tibia is collapsed.Revision surgery is planned.
 
Manufacturer Narrative
Patient sustained a proximal tibial fracture at one day post-op.Surgery occurred to plate the tibia.It was reported that the implants are stable but the tibia is collapsed.Revision surgery is planned.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
karina snow
28 crosby drive
bedford, MA 01730
7813459195
MDR Report Key4906113
MDR Text Key17206935
Report Number3004153240-2015-00122
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
PMA/PMN Number
K111916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 06/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/01/2015
Device Catalogue NumberM57220600210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2014
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 Age85 YR
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