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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 No Known Impact Or Consequence To Patient (2692)
Date of Event 08/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that a conformis iuni patient was revised to an off-the-shelf total knee due to tibial loosening.The surgeon presumed it was a cement issue rather than the implant itself.Review of the device history record indicates that the device was manufactured to specification.
 
Event or Problem Description
It was reported that a conformis iuni patient was revised to an off-the-shelf total knee due to tibial loosening.The surgeon presumed it was a cement issue rather than the implant itself.
 
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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 Key8915754
Report Number3004153240-2019-00201
Device Sequence Number11215487
Product Code HSX
UDI-Device IdentifierM572UKA1111111031
UDI-Public+M572UKA1111111031
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K133256
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/21/2019
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 Health Professional
Device Catalogue NumberUKA-111-1111
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/05/2019
Initial Report FDA Received Date08/21/2019
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 Age56 YR
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