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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number M57230600220
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that a patient had a tka revision to a smith & nephew legion, but with preservation of the iduo patella.The revision was due to patient pain and progression of osteoarthritis within the lateral compartment.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
It was reported that a patient had a tka revision to a smith & nephew legion, but with preservation of the iduo patella.The revision was due to patient pain and progression of osteoarthritis within the lateral compartment.
 
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Brand Name
IDUO G2
Type of Device
BICOMPARTMENTAL 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
emmanuel nyakako
600 technology park drive
billerica, MA 01821
7813459164
MDR Report Key10782096
MDR Text Key214513792
Report Number3004153240-2020-00210
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133256
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 11/03/2020
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
Device Operator Health Professional
Device Catalogue NumberM57230600220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2020
Initial Date FDA Received11/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/17/2014
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;
Patient Age56 YR
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