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

TPLC - Total Product Life Cycle

  • 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
 

New Search Back To Search Results
Device prosthesis, hip, semi-constrained, metal/metal, resurfacing
Definition Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
Product CodeNXT
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
6 6 9 4 7 1 1 5 2 1

Device Problems
No Information 152
No code available 64
Metal shedding debris 31
No Known Device Problem 28
Device operates differently than expected 16
Implant, removal of 14
Fracture 13
Noise, Audible 7
Material integrity issue 7
Dislodged or dislocated 6
Loose or intermittent connection 6
Patient-device incompatibility 5
Slippage of device or device component 4
Break 3
Malposition of device 3
Naturally worn 3
Other (for use when an appropriate device code cannot be identified) 2
Unknown (for use when the device problem is not known) 2
Mechanical issue 2
Migration of device or device component 2
Unintended movement 2
Premature explantation 1
Premature system activation 1
Difficult to remove 1
Collapse 1
Crack 1
Dislodged 1
Sticking 1
Unstable 1
Insufficient flow or underinfusion 1
Fitting problem 1
Device Issue 1
High test results 1
Failure to align 1
Labeling, missing 1
Failure to cut 1
Bent 1
Contamination of device ingredient or reagent 1
Device-device incompatibility 1
No fail-safe mechanism 1
Incompatibility problem 1
Positioning Issue 1
Total Device Problems 393

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II Sep-10-2015

-
-