Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONFORMIS, INC. CONFORMIS HIP SYSTEM; HIP REPLACEMENT SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONFORMIS, INC. CONFORMIS HIP SYSTEM; HIP REPLACEMENT SYSTEM Back to Search Results
Model Number HBS033000001
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 11/05/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the conformis custom stem did not fit properly during surgery.The surgeon had to make an intraoperative conversion to an off-the-shelf stem to complete the procedure.Review of the device history record indicates that the device was manufactured to specification.
 
Event or Problem Description
It was reported that the conformis custom stem did not fit properly during surgery.The surgeon had to make an intraoperative conversion to an off-the-shelf stem to complete the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONFORMIS HIP SYSTEM
Common Device Name
HIP REPLACEMENT SYSTEM
Manufacturer (Section D)
CONFORMIS, INC.
600 technology park drive
billerica MA 01821
MDR Report Key9385568
Report Number3004153240-2019-00291
Device Sequence Number2208239
Product Code LPH
UDI-Device IdentifierM572HBS0330000011
UDI-Public+M572HBS0330000011
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K162719
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/27/2019
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
Operator of Device Health Professional
Device Model NumberHBS033000001
Device Catalogue NumberHBS-033-0000
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/05/2019
Initial Report FDA Received Date11/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age67 YR
-
-