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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. ITOTAL CR; TOTAL KNEE REPAIR SYSTEM
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CONFORMIS, INC. ITOTAL CR; TOTAL KNEE REPAIR SYSTEM Back to Search Results
Model Number M5725INT0600010
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Arthritis (1723)
Event Date 07/22/2022
Event Type  Injury  
Manufacturer Narrative
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is patella resurfacing.Primary surgery occurred on (b)(6) 2018.Revision surgery date is unknown.The device history record was reviewed and the device was manufactured per the specifications.All sterilisation requirements were met.
 
Event Description
It was reported that replacement poly inserts have been requested for revision surgery.Reason for revision is patella resurfacing.Primary surgery occurred on (b)(6) 2018.Revision surgery date is unknown.
 
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Brand Name
ITOTAL CR
Type of Device
TOTAL 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 Key15263627
MDR Text Key298282838
Report Number3004153240-2022-00133
Device Sequence Number1
Product Code JWH
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161366
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 08/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberM5725INT0600010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2018
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) Hospitalization; Required Intervention;
Patient Age81 YR
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