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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Product CodeMRA
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
10 12 14 14 12 28 17 9 18 3

Device Problems
No Information 200
Break 131
Fracture 108
Unknown (for use when the device problem is not known) 104
Implant, removal of 102
Loss of osseointegration 86
Dislodged or dislocated 46
Loose 36
No code available 35
No Known Device Problem 29
Migration of device or device component 25
Component(s), broken 23
Malposition of device 14
Noise, Audible 13
Size incorrect for patient 12
Disassembly 12
Other (for use when an appropriate device code cannot be identified) 10
Crack 8
Metal shedding debris 8
Dislocated 8
Material integrity issue 7
Device remains implanted 6
Loose or intermittent connection 5
Explanted 5
Loss of or failure to bond 4
Corrosion 4
Difficult to insert 4
Fitting problem 4
Detachment of device component 3
Malfunction 3
Mechanical issue 3
Failure to Adhere or Bond 3
Unstable 2
Noise 2
Device operates differently than expected 2
Naturally worn 2
Component(s), worn 2
Displacement 2
Ambient noise issue 2
Dislodged 2
Item contaminated during manufacturing or shipping 2
Material deformation 1
No Pressure 1
Peeled 1
Dent in material 1
Foreign material present in device 1
Material separation 1
Device Issue 1
Device or device component damaged by another device 1
Component incompatible 1
Material fragmentation 1
Positioning Issue 1
Scratched material 1
Failure to disconnect 1
Hermetic seal, loss of 1
Incompatibility problem 1
Unexpected therapeutic results 1
Degraded 1
Mislabeled 1
Total Device Problems 1097

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 1 1 0 1 0 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Sep-05-2008
2 Smith & Nephew Inc II Apr-22-2011
3 Stryker Howmedica Osteonics Corp. II Aug-04-2009
4 Zimmer, Inc. II Feb-20-2014
5 Zimmer, Inc. II Feb-04-2013

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