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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G1; UNICONDYLAR KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. IUNI G1; UNICONDYLAR KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number M57220600010
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 07/01/2018
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 G1
Type of Device
UNICONDYLAR KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
Manufacturer Contact
thomas haueter
600 technology park drive
billerica, MA 01821
7813459161
MDR Report Key7828371
MDR Text Key118615314
Report Number3004153240-2018-00205
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 foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 08/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2010
Device Catalogue NumberM57220600010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2010
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 Age64 YR
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