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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 Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 03/01/2014
Event Type  Injury  
Event Description
Revision surgery occurred due to pain for pt with a unicondylar knee implant.Cement debris was observed in the joint and between the femur and poly.The implants were well fixed.Pt was revised to a total knee replacement.
 
Manufacturer Narrative
Revision surgery occurred due to pain for pt with a unicondylar knee implant.Cement debris was observed in the joint and between the femur and poly.The implants were well fixed.Pt was revised to a total knee replacement.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 dr
bedford MA 01730
Manufacturer Contact
amita shah
28 crosby dr
bedford, MA 01730
7813459164
MDR Report Key3736304
MDR Text Key18569207
Report Number3004153240-2014-00034
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 03/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2011
Device Catalogue NumberM57220600220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2011
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 Age61 YR
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