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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. IDUO; BICOMPARTMENTAL KNEE REPAIR SYSTEM
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CONFORMIS, INC. IDUO; BICOMPARTMENTAL KNEE REPAIR SYSTEM Back to Search Results
Model Number M5723INT0600210
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/09/2022
Event Type  Injury  
Event Description
It was reported that during cementation, both poly size 6's would not seat/lock into the tibial tray.The poly was positioned in place (posterior end first) with the anterior portion slightly above the tray, and the poly impactor was used to attempt to snap into place, as per technique guide.The back of the tibial tray was checked several times for any tissue getting in the way or for discontinuity between the tray and the poly, but was clear.After several attempts with both size 6 inserts, the size 8 was attempted and locked into place on first attempt.There was a major delay of 25 minutes during surgery as a result of this issue.
 
Manufacturer Narrative
It was reported that during cementation, both poly size 6's would not seat/lock into the tibial tray.The poly was positioned in place (posterior end first) with the anterior portion slightly above the tray, and the poly impactor was used to attempt to snap into place, as per technique guide.The back of the tibial tray was checked several times for any tissue getting in the way or for discontinuity between the tray and the poly, but was clear.After several attempts with both size 6 inserts, the size 8 was attempted and locked into place on first attempt.There was a major delay of 25 minutes during surgery as a result of this issue.The device manufacturing records were reviewed, and the device was manufactured per the specifications.All sterilisation requirements were met.
 
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Brand Name
IDUO
Type of Device
BICOMPARTMENTAL KNEE REPAIR SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
Manufacturer (Section G)
CONFORMIS, INC.
600 research drive
wilmington MA 01887
Manufacturer Contact
elizabeth haines
600 technology park drive
billerica, MA 01821
MDR Report Key15565741
MDR Text Key301477266
Report Number3004153240-2022-00159
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K193105
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 10/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM5723INT0600210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2022
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; Hospitalization;
Patient Age61 YR
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