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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 1679
Dislodged or dislocated 1042
No code available 308
Fracture 196
No Known Device Problem 182
Implant, removal of 179
Break 162
Migration of device or device component 97
Loss of osseointegration 83
Unknown (for use when the device problem is not known) 77
Loose or intermittent connection 71
Metal shedding debris 65
Noise, Audible 64
Corrosion 62
Difficult to insert 52
Dislocated 51
Naturally worn 46
Malposition of device 44
Loose 43
Failure to Adhere or Bond 37
Explanted 36
Fitting problem 35
Material erosion 34
Detachment of device component 33
Unstable 31
Tear, rip or hole in device packaging 31
Material integrity issue 27
Mechanical issue 25
Positioning Issue 22
Size incorrect for patient 20
Disassembly 19
Slippage of device or device component 17
Component(s), broken 16
Device-device incompatibility 16
Packaging issue 15
Loss of or failure to bond 14
Difficult to remove 13
Other (for use when an appropriate device code cannot be identified) 13
Device operates differently than expected 13
Foreign material present in device 13
Device markings issue 11
Material deformation 11
Item contaminated during manufacturing or shipping 10
Component missing 10
Difficult to position 10
Material discolored 8
Osseointegration issue 8
Incompatibility problem 8
Patient-device incompatibility 8
Detachment of device or device component 7
Device remains implanted 5
Scratched material 5
Component incompatible 5
Unsealed device packaging 4
Component or accessory incompatibility 4
Mechanics altered 3
Material Protrusion 3
Not Applicable 3
Sticking 3
Retraction problem 3
Material separation 3
Device Issue 3
Failure to osseointegrate 3
Device expiration issue 3
Material fragmentation 3
Device abrasion from instrument or another object 3
Delivered as unsterile product 3
Crack 3
Degraded 2
Blockage within device or device component 2
Nonstandard device or device component 2
Misassembled 2
Improper or incorrect procedure or method 2
Use of Device Issue 2
Device damaged prior to use 2
Defective component 2
Shelf life exceeded 2
Inaccurate synchronization 2
Mechanical jam 2
Manufacturing or shipping issue associated with device 2
Device packaging compromised 2
Malfunction 2
Failure to disconnect 2
Failure to separate 1
Physical resistance 1
Defective item 1
Device or device fragments location unknown 1
Locking mechanism failure 1
Failure to align 1
Failure to advance 1
Dent in material 1
Labeling, missing 1
Delamination 1
Device Contamination with biological material 1
Biological environmental factor 1
Difficult to open or remove packaging material 1
Human-Device Interface Issue 1
Therapeutic or diagnostic output failure 1
Unintended movement 1
Device handling issue 1
Total Device Problems 5183

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 4
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 Jan-17-2017
9 Exactech, Inc. II Jul-05-2016
10 Exactech, Inc. II Jul-21-2014
11 Exactech, Inc. II Feb-05-2013
12 MicroPort Orthopedics Inc. II Jan-03-2017
13 MicroPort Orthopedics Inc. III Dec-01-2016
14 Omnilife Science Inc. II Jul-14-2015
15 Omnilife Science Inc. II Aug-15-2014
16 Ortho Development Corporation II Jan-13-2012
17 Ortho Development Corporation II Mar-16-2011
18 Orthopedic Alliance LLC II May-24-2013
19 Smith & Nephew, Inc. II Aug-29-2017
20 Stryker Howmedica Osteonics Corp. II Sep-28-2012
21 Stryker Howmedica Osteonics Corp. II Nov-16-2011
22 Stryker Howmedica Osteonics Corp. II Mar-11-2010
23 Stryker Howmedica Osteonics Corp. II Jan-11-2010
24 Stryker Howmedica Osteonics Corp. III Sep-14-2009
25 Stryker Howmedica Osteonics Corp. II May-21-2009
26 Stryker Howmedica Osteonics Corp. II Jan-26-2009
27 Stryker Howmedica Osteonics Corp. II Jan-26-2009
28 Stryker Howmedica Osteonics Corp. II Oct-31-2008
29 Wright Medical Technology Inc II Jun-07-2007
30 Zimmer Biomet, Inc. II Mar-20-2017
31 Zimmer Gmbh II Jul-26-2016
32 Zimmer Gmbh II Feb-20-2015
33 Zimmer Inc. II Jul-27-2009
34 Zimmer Inc. II Nov-21-2008
35 Zimmer, Inc. II Feb-27-2015
36 Zimmer, Inc. II Nov-06-2012

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