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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 4

Device Problems
No Information 1748
Implant, removal of 981
No code available 946
Dislodged or dislocated 639
Dislocated 356
Metal shedding debris 305
Loose 272
Unknown (for use when the device problem is not known) 226
Component(s), worn 174
Loss of osseointegration 171
Explanted 164
Corrosion 128
Naturally worn 124
Break 119
Noise, Audible 112
Fracture 109
Loss of or failure to bond 68
Disassembly 59
Loose or intermittent connection 56
Device remains implanted 55
Malposition of device 53
Migration of device or device component 53
Fitting problem 52
Other (for use when an appropriate device code cannot be identified) 45
Component(s), broken 33
Difficult to insert 29
Material erosion 23
No Known Device Problem 23
Device, or device fragments remain in patient 17
Foreign material present in device 14
Size incorrect for patient 13
Slippage of device or device component 13
Detachment of device component 12
Incompatibility problem 10
Device operates differently than expected 9
Material integrity issue 7
Tear, rip or hole in device packaging 7
Unstable 7
Difficult to remove 6
Malfunction 6
Device damaged prior to use 6
Mechanical issue 6
Component incompatible 4
Component missing 4
Incomplete or missing packaging 3
Material separation 3
Device Issue 3
Failure to osseointegrate 3
Improper or incorrect procedure or method 3
Foreign material 3
Mislabeled 3
Positioning Issue 3
Mechanical jam 2
Item contaminated during manufacturing or shipping 2
Nonstandard device or device component 2
Unsealed device packaging 2
Misassembled 2
Inadequate instructions for healthcare professional 2
Material discolored 2
Disengaged 2
Crack 2
Replace 2
Device Difficult to Setup or Prepare 2
Seal, defective 2
Defective component 1
Surgical graft, failure of 1
Internal fixation, revision of 1
Failure to disconnect 1
Patient-device incompatibility 1
Ambient noise issue 1
Connection issue 1
User used incorrect product for intended use 1
Sticking 1
Insufficient flow or underinfusion 1
Failure to unfold or unwrap 1
Degraded 1
Design/structure problem 1
Bent 1
Device expiration issue 1
Elective removal 1
Lens, discoloration of 1
Device abrasion from instrument or another object 1
Gradient increase 1
Excess flow or overinfusion 1
Misapplication 1
Particulates 1
Difficult to position 1
Device-device incompatibility 1
Scratched material 1
Unintended movement 1
Not Applicable 1
Osseointegration issue 1
Total Device Problems 7340

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 2 1 2 1 0 1 2 2 0 3 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 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 Smith & Nephew, Inc. II Nov-03-2016
8 Stryker Howmedica Osteonics Corp. II Sep-11-2008
9 Wright Medical Technology Inc II Mar-07-2007
10 Zimmer Biomet, Inc. II Feb-22-2016
11 Zimmer Manufacturing B.V. II Mar-12-2016
12 Zimmer, Inc. II Feb-20-2014
13 Zimmer, Inc. II Oct-25-2013
14 Zimmer, Inc. II Nov-20-2012

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