Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONFORMIS, INC. IDUO G2; BICOMPARTMENTAL KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number M57230600220
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 11/01/2015
Event Type  Injury  
Manufacturer Narrative
Patient with a bicompartmental knee implant was having patellofemoral issues, mobility issues, and painful pop with range of motion.An arthroscopy procedure, lateral release, debridement and shaving of articular cartilage, and removal of loose or foreign body occurred.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
Patient with a bicompartmental knee implant was having patellofemoral issues, mobility issues, and painful pop with range of motion.An arthroscopy procedure, lateral release, debridement and shaving of articular cartilage, and removal of loose or foreign body occurred.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5260100
MDR Text Key32457713
Report Number3004153240-2015-00222
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,study
Reporter Occupation Other
Type of Report Initial
Report Date 12/02/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date07/31/2015
Device Catalogue NumberM57230600220
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2015
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 Age55 YR
-
-