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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. CONFORMIS HIP SYSTEM; HIP REPLACEMENT SYSTEM
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CONFORMIS, INC. CONFORMIS HIP SYSTEM; HIP REPLACEMENT SYSTEM Back to Search Results
Model Number HBS033000001
Device Problem Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Code Available (3191)
Event Date 08/26/2019
Event Type  Injury  
Manufacturer Narrative
It was reported that the size 15 hip stem did not fit.The size 15 broach countersunk below the neck resection and as a result the conformis stem was not implanted and a djo stem and head were implanted.Review of the device history record indicates that the device was manufactured to specification.
 
Event Description
It was reported that the size 15 hip stem did not fit.The size 15 broach countersunk below the neck resection and as a result the conformis stem was not implanted and a djo stem and head were implanted.
 
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Brand Name
CONFORMIS HIP SYSTEM
Type of Device
HIP 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
paul smolenski
600 technology park drive
billerica, MA 01821
7813459093
MDR Report Key9099265
MDR Text Key162813165
Report Number3004153240-2019-00223
Device Sequence Number1
Product Code LPH
UDI-Device IdentifierM572HBS0330000011
UDI-Public+M572HBS0330000011
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162719
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 09/20/2019
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 Model NumberHBS033000001
Device Catalogue NumberHBS-033-0000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/26/2019
Initial Date FDA Received09/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2019
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 Age86 YR
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