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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Regulation Description Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
Product CodeKWY
Regulation Number 888.3390
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 4
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 6
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARBOMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
IMPLEX
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  1
  SUBSTANTIALLY EQUIVALENT 8
OMNI
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT
  1
  SUBSTANTIALLY EQUIVALENT 4
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Information 1345
Implant, removal of 981
Dislodged or dislocated 512
No code available 507
Dislocated 356
Loose 272
Metal shedding debris 232
Unknown (for use when the device problem is not known) 226
Component(s), worn 174
Explanted 164
Loss of osseointegration 146
Break 108
Naturally worn 99
Fracture 96
Corrosion 81
Noise, Audible 74
Loss of or failure to bond 64
Device remains implanted 55
Loose or intermittent connection 55
Fitting problem 48
Other (for use when an appropriate device code cannot be identified) 45
Migration of device or device component 44
Disassembly 44
Malposition of device 37
Component(s), broken 33
Difficult to insert 28
No Known Device Problem 20
Device, or device fragments remain in patient 17
Foreign material present in device 14
Slippage of device or device component 13
Size incorrect for patient 11
Incompatibility problem 10
Detachment of device component 10
Device operates differently than expected 9
Tear, rip or hole in device packaging 7
Material erosion 7
Malfunction 6
Device damaged prior to use 6
Mechanical issue 5
Difficult to remove 4
Component incompatible 4
Component missing 4
Material integrity issue 4
Incomplete or missing packaging 3
Device Issue 3
Unstable 3
Material separation 3
Failure to osseointegrate 3
Improper or incorrect procedure or method 3
Foreign material 3
Mislabeled 3
Unsealed device packaging 2
Replace 2
Inadequate instructions for healthcare professional 2
Disengaged 2
Crack 2
Seal, defective 2
Positioning Issue 2
Unintended movement 1
Mechanical jam 1
Osseointegration issue 1
Defective component 1
Failure to unfold or unwrap 1
Insufficient flow or underinfusion 1
Sticking 1
Internal fixation, revision of 1
Failure to disconnect 1
Surgical graft, failure of 1
Patient-device incompatibility 1
Connection issue 1
Item contaminated during manufacturing or shipping 1
Design/structure problem 1
Material discolored 1
Elective removal 1
Device expiration issue 1
Lens, discoloration of 1
Gradient increase 1
Excess flow or overinfusion 1
Misapplication 1
Misassembled 1
Particulates 1
User used incorrect product for intended use 1
Nonstandard device or device component 1
Total Device Problems 6040

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 2 1 2 1 0 1 2 2 0 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Nov-07-2007
2 Omni Life Science II Sep-10-2009
3 Ortho Development Corporation II Aug-17-2014
4 Ortho Development Corporation II Nov-03-2010
5 Ortho Development Corporation II Oct-28-2009
6 Orthopedic Alliance LLC II May-24-2013
7 Stryker Howmedica Osteonics Corp. II Sep-11-2008
8 Wright Medical Technology Inc II Mar-07-2007
9 Zimmer Biomet, Inc. II Feb-22-2016
10 Zimmer Manufacturing B.V. II Mar-12-2016
11 Zimmer, Inc. II Feb-20-2014
12 Zimmer, Inc. II Oct-25-2013
13 Zimmer, Inc. II Nov-20-2012

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