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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
Model Number UKA-111-1111
Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 07/01/2022
Event Type  Injury  
Manufacturer Narrative
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is laxity.Primary surgery occurred on (b)(6) 2022.Revision surgery is planned for (b)(6) 2022.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 laxity.Primary surgery occurred on (b)(6) 2022.Revision surgery is planned for (b)(6) 2022.
 
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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 Key15136905
MDR Text Key296950483
Report Number3004153240-2022-00122
Device Sequence Number1
Product Code HSX
UDI-Device IdentifierM572UKA1111111031
UDI-PublicM572UKA1111111031
Combination Product (y/n)N
Reporter Country CodeUS
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 07/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUKA-111-1111
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2022
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; Hospitalization;
Patient Age47 YR
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