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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 UKA-111-1111
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 05/01/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the patient is clinically unstable.It was also reported that the 6 mm poly insert originally implanted is too small.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 or Problem Description
It was reported that the patient is clinically unstable.It was also reported that the 6 mm poly insert originally implanted is too small.A revision surgery is planned to exchange the poly insert.
 
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Brand Name
IUNI G2
Common Device Name
UNICONDYLAR KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS.INC.
600 technology park drive
billerica MA 01821
MDR Report Key7537637
Report Number3004153240-2018-00109
Device Sequence Number275233
Product Code HSX
UDI-Device IdentifierM572UKA1111111031
UDI-Public+M572UKA1111111031
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K133256
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/23/2018
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
Operator of Device Physician
Device Expiration Date04/30/2018
Device Catalogue NumberUKA-111-1111
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/04/2018
Initial Report FDA Received Date05/23/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age45 YR
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