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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS IDUO G2; BIOCOMPARTMENTAL KNEE REPLACEMENT SYSTEM
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CONFORMIS IDUO G2; BIOCOMPARTMENTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number M57230600220
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 12/01/2014
Event Type  Injury  
Event Description
Patient was experiencing pain and decreased range of motion.Arthroscopy procedure was performed.
 
Manufacturer Narrative
Patient was experiencing pain and decreased range of motion.Arthroscopy procedure was performed.Review of the device history record indicates that the device was manufactured to specification.
 
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Brand Name
IDUO G2
Type of Device
BIOCOMPARTMENTAL 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 Key4372978
MDR Text Key20012881
Report Number3004153240-2014-00181
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093513
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 12/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/01/2014
Device Catalogue NumberM57230600220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2013
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 Age54 YR
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