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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 M57230600210
Device Problem Fracture (1260)
Patient Problems Fall (1848); Failure of Implant (1924)
Event Date 10/01/2014
Event Type  Injury  
Event Description
Pt with a bicompartmental knee implant fell and experienced a tibial fracture.Revision surgery is planned to replace the tibial implants.
 
Manufacturer Narrative
Pt with a bicompartmental knee implant fell and experienced a tibial fracture.Revision surgery is planned to replace the tibial implants.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
BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
28 crosby drive
bedford MA 01730
Manufacturer Contact
karina snow
28 crosby drive
bedford, MA 01730
7813459195
MDR Report Key4254686
MDR Text Key5045925
Report Number3004153240-2014-00149
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 10/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/01/2011
Device Catalogue NumberM57230600210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2011
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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