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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product CodeLZO
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 6
APEX
  SUBSTANTIALLY EQUIVALENT 2
BIOMET
  2
  SUBSTANTIALLY EQUIVALENT 22
BIOPRO, INC.
  1
  SUBSTANTIALLY EQUIVALENT 2
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
DEPUY INTL., LTD.
  4
  SUBSTANTIALLY EQUIVALENT 18
DOW
  1
  SUBSTANTIALLY EQUIVALENT 6
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
EXACTECH, INC.
  1
  SUBSTANTIALLY EQUIVALENT 16
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
HAYES
  SUBSTANTIALLY EQUIVALENT 2
IMPLEX
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  1
  SUBSTANTIALLY EQUIVALENT 2
JOINT MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
KINAMED, INC.
  3
  SUBSTANTIALLY EQUIVALENT 9
OMNI
  SUBSTANTIALLY EQUIVALENT 4
ORTHO DEVELOPMENT
  1
  SUBSTANTIALLY EQUIVALENT 5
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 6
PORTLAND ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 21
STELKAST
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  4
  SUBSTANTIALLY EQUIVALENT 30
SULZER
  1
  SUBSTANTIALLY EQUIVALENT 8
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 11
ZIMMER, INC.
  3
  SUBSTANTIALLY EQUIVALENT 19

Device Problems
No Information 1015
Dislodged or dislocated 701
No code available 226
Implant, removal of 179
Fracture 156
Break 122
No Known Device Problem 120
Unknown (for use when the device problem is not known) 77
Loose or intermittent connection 71
Loss of osseointegration 59
Dislocated 51
Difficult to insert 46
Loose 43
Migration of device or device component 41
Metal shedding debris 40
Noise, Audible 40
Explanted 36
Failure to Adhere or Bond 33
Fitting problem 32
Detachment of device component 32
Naturally worn 26
Malposition of device 26
Tear, rip or hole in device packaging 25
Disassembly 20
Material erosion 20
Mechanical issue 19
Corrosion 19
Material integrity issue 19
Unstable 17
Slippage of device or device component 17
Component(s), broken 16
Other (for use when an appropriate device code cannot be identified) 13
Size incorrect for patient 13
Loss of or failure to bond 13
Device operates differently than expected 12
Foreign material present in device 12
Device-device incompatibility 11
Positioning Issue 11
Difficult to remove 11
Component missing 10
Item contaminated during manufacturing or shipping 10
Device markings issue 9
Packaging issue 9
Patient-device incompatibility 8
Osseointegration issue 8
Material discolored 8
Incompatibility problem 6
Device remains implanted 5
Component incompatible 4
Difficult to position 4
Crack 3
Mechanics altered 3
Material separation 3
Material fragmentation 3
Material Protrusion 3
Failure to osseointegrate 3
Not Applicable 3
Retraction problem 2
Degraded 2
Delivered as unsterile product 2
Inaccurate synchronization 2
Defective component 2
Improper or incorrect procedure or method 2
Mechanical jam 2
Component or accessory incompatibility 2
Unsealed device packaging 2
Sticking 2
Failure to disconnect 2
Malfunction 2
Scratched material 2
Device damaged prior to use 2
Shelf life exceeded 2
Device expiration issue 2
Detachment of device or device component 2
Collapse 1
Device or device fragments location unknown 1
Nonstandard device or device component 1
Insulation degradation 1
Failure to align 1
Defective item 1
Material perforation 1
Displacement 1
Disconnection 1
Reaction 1
Component(s), worn 1
Device Contamination with biological material 1
Lens, repositioning of 1
Blockage within device or device component 1
Unintended movement 1
Material deformation 1
Dent in material 1
Out-of-box failure 1
Device packaging compromised 1
Device Issue 1
Failure to separate 1
User used incorrect product for intended use 1
Failure to advance 1
Noise 1
Pitted 1
Labeling, missing 1
Total Device Problems 3602

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 1 2 5 2 3 5 2 3 3 4 1
Class III 0 0 1 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Inc II Aug-12-2011
2 Biomet, Inc. II Jan-13-2016
3 Biomet, Inc. II Apr-23-2012
4 Biomet, Inc. II Mar-02-2012
5 Biomet, Inc. II Jul-14-2009
6 Corin USA Limited II Apr-22-2016
7 DePuy Orthopaedics, Inc. II Dec-17-2014
8 Exactech, Inc. II Jul-05-2016
9 Exactech, Inc. II Jul-21-2014
10 Exactech, Inc. II Feb-05-2013
11 MicroPort Orthopedics Inc. II Jan-03-2017
12 MicroPort Orthopedics Inc. III Dec-01-2016
13 Omnilife Science Inc. II Jul-14-2015
14 Omnilife Science Inc. II Aug-15-2014
15 Ortho Development Corporation II Jan-13-2012
16 Ortho Development Corporation II Mar-16-2011
17 Orthopedic Alliance LLC II May-24-2013
18 Stryker Howmedica Osteonics Corp. II Sep-28-2012
19 Stryker Howmedica Osteonics Corp. II Nov-16-2011
20 Stryker Howmedica Osteonics Corp. II Mar-11-2010
21 Stryker Howmedica Osteonics Corp. II Jan-11-2010
22 Stryker Howmedica Osteonics Corp. III Sep-14-2009
23 Stryker Howmedica Osteonics Corp. II May-21-2009
24 Stryker Howmedica Osteonics Corp. II Jan-26-2009
25 Stryker Howmedica Osteonics Corp. II Jan-26-2009
26 Stryker Howmedica Osteonics Corp. II Oct-31-2008
27 Wright Medical Technology Inc II Jun-07-2007
28 Zimmer Gmbh II Jul-26-2016
29 Zimmer Gmbh II Feb-20-2015
30 Zimmer Inc. II Jul-27-2009
31 Zimmer Inc. II Nov-21-2008
32 Zimmer, Inc. II Feb-27-2015
33 Zimmer, Inc. II Nov-06-2012

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