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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 Pain (1994)
Date of Event 04/01/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the patient is having recurring pain in the knee.The surgeon believes the patient may have a lateral meniscus tear.A procedure is planned to perform a diagnostic scope.Poly insert replacement may be required.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 having recurring pain in the knee.The surgeon believes the patient may have a lateral meniscus tear.A procedure is planned to perform a diagnostic scope.Poly insert replacement may be required.
 
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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 Key6583929
Report Number3004153240-2017-00114
Device Sequence Number16169555
Product Code HSX
UDI-Device IdentifierM572UKA1111111031
UDI-Public+M572UKA1111111031
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K161366
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/23/2017
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 Date01/31/2017
Device Catalogue NumberUKA-111-1111
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/28/2017
Initial Report FDA Received Date05/23/2017
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 Age54 YR
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