• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. NOVATION ELEMENT FEMORAL STEM, 12/14, COLLARLESS, STANDARD OFFSET, HA COATED, PR

  • 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
 

EXACTECH, INC. NOVATION ELEMENT FEMORAL STEM, 12/14, COLLARLESS, STANDARD OFFSET, HA COATED, PR Back to Search Results
Catalog Number 164-01-11
Device Problems Loss of Osseointegration (2408); Deformation Due to Compressive Stress (2889); Device Operates Differently Than Expected (2913)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Joint Disorder (2373)
Event Date 10/13/2017
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2013. Revision of hip components due to implant failure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNOVATION ELEMENT FEMORAL STEM, 12/14, COLLARLESS, STANDARD OFFSET, HA COATED, PR
Type of DeviceFEMORAL STEM
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th court
gainesville, FL 32653
3523771140
MDR Report Key7303825
MDR Text Key101197724
Report Number1038671-2018-00215
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Attorney
Type of Report Initial,Followup
Report Date 03/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/14/2017
Device Catalogue Number164-01-11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/28/2018 Patient Sequence Number: 1
-
-