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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 M5723INT0600210
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Code Available (3191)
Event Date 08/01/2014
Event Type  Injury  
Event Description
Ligament tension was reported to be loose for patient with a bicompartmental knee implant.Revision surgery is planned to exchange the poly insert.
 
Manufacturer Narrative
Ligament tension was reported to be loose for patient with a bicompartmental knee implant.Revision surgery is planned to exchange the poly insert.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
28 crosby drive
bedford MA 01730
Manufacturer Contact
karina snow
28 crosby drive
bedford, MA 01730
7813459195
MDR Report Key4054172
MDR Text Key20659579
Report Number3004153240-2014-00122
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
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 08/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/01/2013
Device Catalogue NumberM5723INT0600210
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2013
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 Age70 YR
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