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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
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CONFORMIS IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number M5723INT0600220
Device Problems Break (1069); Off-Label Use (1494)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2014
Event Type  malfunction  
Event Description
The incorrect disposable drill kit and disposable pin kit were provided within the implant kit.The surgeon proceeded using a smaller tibial drill to drill the femoral peg holes.The disposable femoral trial broke during trialing.This reportedly occurred because the femoral holes drilled using the smaller drill were not deep enough for the femoral trial pegs.The surgeon re-drilled the holes and trialed using the femoral implant.The procedure was extended by approx 10 minutes.A good outcome was achieved.
 
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Brand Name
IDUO G2
Type of Device
BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS
28 crosby dr
bedford MA 01730
Manufacturer Contact
karina snow
28 crosby dr
bedford, MA 01730
7813459195
MDR Report Key4365458
MDR Text Key5232898
Report Number3004153240-2014-00178
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K093513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2015
Device Catalogue NumberM5723INT0600220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2014
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 Age62 YR
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