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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
Catalog Number M57230600210
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 08/30/2021
Event Type  Injury  
Manufacturer Narrative
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is infection.Primary surgery occurred on (b)(6) 2020.Revision surgery is planned for (b)(6) 2021.Review of the device history record indicates that the device was manufactured to specification.All sterilisation requirements were met.
 
Event Description
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is infection.Primary surgery occurred on (b)(6) 2020.Revision surgery is planned for (b)(6) 2021.
 
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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
kara johnson
600 technology park drive
billerica, MA 01821
MDR Report Key12549136
MDR Text Key273877678
Report Number3004153240-2021-00166
Device Sequence Number1
Product Code NPJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K133256
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 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberM57230600210
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/30/2021
Initial Date FDA Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/13/2020
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 Age62 YR
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