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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM
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CONFORMIS, INC IUNI G2; UNICONDYLAR KNEE REPLACEMENT SYSTEM Back to Search Results
Catalog Number M5722INT0600220
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Information (3190)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
It was reported that one end of the inner pouch of the femoral implant had not been sealed.The femoral implant was re-sterilized.Surgery was completed successfully.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
It was reported that one end of the inner pouch of the femoral implant had not been sealed.The femoral implant was re-sterilized.Surgery was completed successfully.
 
Manufacturer Narrative
It was reported that one end of the inner pouch of the femoral implant had not been sealed.As the inner pouch was removed from the outer pouch, the femoral implant fell out of the bottom of the inner pouch onto the floor.The femoral implant was re-sterilized.The case was completed successfully after 1.5 hour delay.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
It was reported that one end of the inner pouch of the femoral implant had not been sealed.As the inner pouch was removed from the outer pouch, the femoral implant fell out of the bottom of the inner pouch onto the floor.The femoral implant was re-sterilized.The case was completed successfully after 1.5 hour delay.
 
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Brand Name
IUNI G2
Type of Device
UNICONDYLAR KNEE REPLACEMENT 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
karina snow
600 technology park drive
billerica, MA 01821
7813459195
MDR Report Key7247018
MDR Text Key99328081
Report Number3004153240-2018-00022
Device Sequence Number1
Product Code HSX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K133256
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date07/31/2018
Device Catalogue NumberM5722INT0600220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2018
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 Age56 YR
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