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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 2017
10 12 14 14 12 28 17 9 18 26 5

Device Problems
Break 277
No Information 266
Fracture 132
Unknown (for use when the device problem is not known) 104
Loss of osseointegration 103
Implant, removal of 102
Dislodged or dislocated 71
No code available 55
No Known Device Problem 36
Loose 36
Migration of device or device component 34
Noise, Audible 28
Component(s), broken 23
Disassembly 22
Crack 19
Malposition of device 17
Size incorrect for patient 12
Other (for use when an appropriate device code cannot be identified) 10
Corrosion 10
Metal shedding debris 9
Material integrity issue 9
Dislocated 8
Loss of or failure to bond 7
Loose or intermittent connection 7
Device remains implanted 6
Mechanical issue 5
Explanted 5
Difficult to insert 4
Unstable 4
Fitting problem 4
Failure to Adhere or Bond 4
Detachment of device component 3
Degraded 3
Naturally worn 3
Malfunction 3
Item contaminated during manufacturing or shipping 2
Ambient noise issue 2
Device operates differently than expected 2
Failure to disconnect 2
Dislodged 2
Displacement 2
Component(s), worn 2
Component incompatible 2
Noise 2
Unexpected therapeutic results 1
Difficult to remove 1
Material separation 1
Mislabeled 1
Peeled 1
Bent 1
Material fragmentation 1
Disconnection 1
No Pressure 1
Positioning Issue 1
Scratched material 1
Device or device component damaged by another device 1
Foreign material present in device 1
Incompatibility problem 1
Material deformation 1
Dent in material 1
Hermetic seal, loss of 1
Device Issue 1
Component missing 1
Total Device Problems 1478

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 1 0 1 0 1 1 0 1 0
Class III 0 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 Exactech, Inc. II Jun-02-2016
3 Smith & Nephew Inc II Apr-22-2011
4 Stryker Howmedica Osteonics Corp. II Aug-04-2009
5 Zimmer, Inc. II Feb-20-2014
6 Zimmer, Inc. II Feb-04-2013

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