• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device prosthesis, hip, semi-constrained (metal uncemented acetabular component)
Regulation Description Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Product CodeKWA
Regulation Number 888.3330
Device Class 3


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 25
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 19
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
KINAMED, INC.
  1
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
SULZER
  SUBSTANTIALLY EQUIVALENT 4
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 26
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 9

Device Problems
No Information 28615
No code available 5951
Metal shedding debris 5186
Loss of osseointegration 3487
Dislodged or dislocated 1792
Noise, Audible 1629
Implant, removal of 1539
Corrosion 910
Loose 845
Malposition of device 824
Naturally worn 672
No Known Device Problem 639
Loss of or failure to bond 618
Migration of device or device component 542
Material erosion 538
Loose or intermittent connection 481
Unknown (for use when the device problem is not known) 431
Fracture 322
Dislocated 240
Disassembly 239
Break 224
Other (for use when an appropriate device code cannot be identified) 193
Nonstandard device or device component 154
Device remains implanted 149
Explanted 144
Component(s), worn 129
Device Issue 84
Device operates differently than expected 84
Mechanical issue 80
Unstable 78
Incompatibility problem 75
Slippage of device or device component 74
Failure to osseointegrate 65
Difficult to remove 64
Size incorrect for patient 53
Patient-device incompatibility 51
Osseointegration issue 40
Failure to separate 39
Positioning Issue 35
Material integrity issue 34
Failure to Adhere or Bond 34
Detachment of device component 23
Degraded 15
Malfunction 15
Component or accessory incompatibility 12
Device packaging compromised 12
Difficult to insert 12
Material separation 11
Component incompatible 10
Fitting problem 10
Component missing 9
Component(s), broken 9
Material discolored 9
Difficult to position 9
Displacement 8
Device-device incompatibility 8
Unintended movement 7
Replace 7
Failure to disconnect 6
Material deformation 5
Not Applicable 5
Device abrasion from instrument or another object 5
Membrane leak(s) 5
Dislodged 5
Entrapment of device or device component 4
Foreign material present in device 4
Material Protrusion 4
Detachment of device or device component 4
Device markings issue 4
Defective item 4
Improper or incorrect procedure or method 4
Tear, rip or hole in device packaging 3
Delamination 3
Ambient noise issue 3
Mechanical jam 3
Device or device component damaged by another device 3
Scratched material 3
Excess flow or overinfusion 3
Unsealed device packaging 3
User used incorrect product for intended use 3
Reaction 3
Fluid leak 3
Crack 3
Collapse 3
Disconnection 2
Disengaged 2
Sticking 2
Peeled 2
Product quality issue 2
Item contaminated during manufacturing or shipping 2
Electrical shorting 2
Computer operating system issue 2
Device or device fragments location unknown 2
Failure to align 2
Dull 2
Inadequate filtration process 2
Defective component 2
Device damaged prior to use 1
Noise 1
Out-of-box failure 1
Total Device Problems 57696

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 1 0 0
Class II 0 1 1 1 3 5 1 1 2 1 1
Class III 0 1 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Feb-17-2015
2 Biomet, Inc. II Nov-27-2012
3 Biomet, Inc. II Nov-21-2012
4 Biomet, Inc. II Jun-08-2011
5 Biomet, Inc. II Mar-07-2011
6 DePuy Orthopaedics, Inc. II Jul-21-2014
7 Depuy Orthopaedics, Inc. II Mar-24-2011
8 Depuy Orthopaedics, Inc. II Jul-17-2010
9 Encore Medical, Lp II Feb-11-2017
10 Wright Medical Technology Inc II Feb-14-2012
11 Zimmer Biomet, Inc. II Feb-22-2016
12 Zimmer Gmbh II Feb-20-2015
13 Zimmer Inc. II Nov-13-2009
14 Zimmer Inc. II Sep-26-2008
15 Zimmer Inc. III Sep-17-2008
16 Zimmer, Inc. I Jun-08-2015
17 Zimmer, Inc. II Oct-25-2013
18 Zimmer, Inc. II Nov-06-2012
19 Zimmer, Inc. II Aug-16-2012

-
-