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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IDUO; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC. IDUO; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number UNKNOWN
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 05/01/2016
Event Type  Injury  
Manufacturer Narrative
It was reported that the patient had pain and effusion post-operatively.Femoral implant loosening was identified.The patient was revised to a total knee replacement system.Device identifying information was not provided.Review of the device history record was not possible as the serial number of the device was not reported.
 
Event Description
It was reported that the patient had pain and effusion post-operatively.Femoral implant loosening was identified.The patient was revised to a total knee replacement system.
 
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Brand Name
IDUO
Type of Device
BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
28 crosby dr.
bedford MA 01730
Manufacturer Contact
karina snow
28 crosby dr.
bedford, MA 01730
7813459195
MDR Report Key5744856
MDR Text Key48028844
Report Number3004153240-2016-00135
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 company representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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