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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IUNI; UNICONDYLAR KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. IUNI; UNICONDYLAR KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number M5722INT0600220
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem Loss of Range of Motion (2032)
Event Date 05/01/2016
Event Type  Injury  
Manufacturer Narrative
It was reported that the patient has tibial implant loosening and laxity or limited range of motion.A revision surgery is planned to exchange the tibial tray and poly insert.Review of the device history record indicates the device was manufactured to specification.
 
Event Description
It was reported that the patient has tibial implant loosening and laxity or limited range of motion.A revision surgery is planned to exchange the tibial tray and poly insert.
 
Manufacturer Narrative
It was originally reported that the patient had tibial implant loosening and laxity or limited range of motion.A revision surgery occurred.It was confirmed during revision surgery that the tibial implant was loose.The patient did not have laxity or limited range of motion.Review of the device history record indicates the device was manufactured to specification.
 
Event Description
It was originally reported that the patient had tibial implant loosening and laxity or limited range of motion.A revision surgery occurred.It was confirmed during revision surgery that the tibial implant was loose.The patient did not have laxity or limited range of motion.
 
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Brand Name
IUNI
Type of Device
UNICONDYLAR KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
28 crosby dr.
bedford MA 01730
Manufacturer Contact
karina snow
28 crosby dr.
bedford, MA 01730
7813459195
MDR Report Key5744836
MDR Text Key48028304
Report Number3004153240-2016-00134
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K111916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date04/30/2015
Device Catalogue NumberM5722INT0600220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2014
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 Age39 YR
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