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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number UKA-111-1111
Device Problem Malposition of Device (2616)
Patient Problem No Code Available (3191)
Event Date 10/01/2017
Event Type  malfunction  
Manufacturer Narrative
It was reported that the 8mm poly insert did not properly sit in the tray during surgery.The 6mm poly insert was implanted to complete the case.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
It was reported that the 8mm poly insert did not properly sit in the tray during surgery.The 6mm poly insert was implanted to complete the case.
 
Manufacturer Narrative
It was reported that the 8mm poly insert did not properly sit in the tray during surgery.The 6mm poly insert was implanted to complete the case.Review of the device history record indicates that the device was manufactured to specification.Returned device evaluation: the 8mm poly was returned for evaluation.The anterior interlock showed some signs of fraying along the edge, which is typical for an insert that has had the anterior tab engaged with the interlock.It is likely that the anterior tab was engaged somewhat during surgery.Review of the returned insert was inconclusive.
 
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Brand Name
IUNI G2
Type of Device
UNICONDYLAR KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
Manufacturer (Section G)
CONFORMIS, INC.
600 research drive
wilmington MA 01887
Manufacturer Contact
karina snow
600 technology park
billerica, MA 01821
7813459195
MDR Report Key7008694
MDR Text Key92606105
Report Number3004153240-2017-00241
Device Sequence Number1
Product Code HSX
UDI-Device IdentifierM572UKA1111111031
UDI-Public+M572UKA1111111031
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133256
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date04/30/2018
Device Catalogue NumberUKA-111-1111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2017
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 Age44 YR
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