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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IUNI; UNICONDYLAR KNEE REPAIR SYSTEM
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CONFORMIS, INC. IUNI; UNICONDYLAR KNEE REPAIR SYSTEM Back to Search Results
Catalog Number M5722INT0600220
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 05/31/2022
Event Type  Injury  
Manufacturer Narrative
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is infection.Primary surgery occurred on (b)(6) 2021.Revision surgery date is unknown.The device history record was reviewed and the device was manufactured per the specifications.All sterilisation requirements were met.
 
Event Description
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is infection.Primary surgery occurred on (b)(6) 2021.Revision surgery date is unknown.
 
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Brand Name
IUNI
Type of Device
UNICONDYLAR KNEE REPAIR 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 Key14879401
MDR Text Key295123799
Report Number3004153240-2022-00102
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K193105
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 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberM5722INT0600220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/18/2021
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) Hospitalization; Required Intervention;
Patient Age74 YR
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