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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 M57220600210
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 12/14/2021
Event Type  Injury  
Event Description
It was reported that replacement poly inserts (6mm) have been requested for revision surgery.Reason for revision is because another procedure is required on the affected joint during which the poly inserts will be replaced.The required procedure is unknown.Primary surgery occurred on (b)(6) 2011.Revision surgery date is unknown.
 
Manufacturer Narrative
It was reported that replacement poly inserts (6mm) have been requested for revision surgery.Reason for revision is because another procedure is required on the affected joint during which the poly inserts will be replaced.The required procedure is unknown.Primary surgery occurred on (b)(6) 2011.Revision surgery date is unknown.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.
 
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Brand Name
IUNI
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
kara johnson
600 technology park drive
billerica, MA 01821
MDR Report Key13255358
MDR Text Key283809000
Report Number3004153240-2022-00007
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeGM
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 01/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberM57220600210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2011
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 Age68 YR
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