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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 M57220600210
Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)
Patient Problem Failure of Implant (1924)
Event Date 12/01/2017
Event Type  Injury  
Manufacturer Narrative
It was reported that the patient has loose or dislocated poly insert.A revision surgery is planned to exchange the poly insert.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
It was reported that the patient has loose or dislocated poly insert.A revision surgery is planned to exchange the poly insert.
 
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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 Contact
karina snow
600 technology park drive
billerica, MA 01821
7813459195
MDR Report Key7177993
MDR Text Key96824004
Report Number3004153240-2018-00009
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121974
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 01/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date08/31/2013
Device Catalogue NumberM57220600210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/28/2017
Initial Date FDA Received01/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2013
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 Age52 YR
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