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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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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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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 3

Device Problems
No Information 256
Break 231
Fracture 130
Unknown (for use when the device problem is not known) 104
Implant, removal of 102
Loss of osseointegration 101
Dislodged or dislocated 65
No code available 53
Loose 36
Migration of device or device component 34
No Known Device Problem 32
Noise, Audible 24
Component(s), broken 23
Disassembly 20
Crack 17
Malposition of device 17
Size incorrect for patient 12
Other (for use when an appropriate device code cannot be identified) 10
Metal shedding debris 9
Corrosion 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 1397

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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