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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 966
Dislodged or dislocated 678
No code available 221
Implant, removal of 179
Fracture 151
Break 116
No Known Device Problem 116
Unknown (for use when the device problem is not known) 77
Loose or intermittent connection 71
Loss of osseointegration 56
Dislocated 51
Difficult to insert 46
Loose 43
Metal shedding debris 40
Migration of device or device component 37
Explanted 36
Noise, Audible 34
Failure to Adhere or Bond 33
Fitting problem 32
Detachment of device component 31
Malposition of device 26
Naturally worn 25
Tear, rip or hole in device packaging 25
Disassembly 19
Material erosion 18
Mechanical issue 18
Material integrity issue 18
Corrosion 17
Slippage of device or device component 17
Unstable 17
Component(s), broken 16
Loss of or failure to bond 13
Size incorrect for patient 13
Other (for use when an appropriate device code cannot be identified) 13
Device operates differently than expected 12
Device-device incompatibility 10
Foreign material present in device 10
Item contaminated during manufacturing or shipping 10
Positioning Issue 10
Component missing 10
Difficult to remove 10
Packaging issue 9
Device markings issue 9
Osseointegration issue 8
Material discolored 8
Patient-device incompatibility 7
Incompatibility problem 6
Device remains implanted 5
Material separation 3
Failure to osseointegrate 3
Crack 3
Component incompatible 3
Material fragmentation 3
Not Applicable 3
Material Protrusion 3
Mechanics altered 3
Mechanical jam 2
Scratched material 2
Component or accessory incompatibility 2
Detachment of device or device component 2
Failure to disconnect 2
Device expiration issue 2
Delivered as unsterile product 2
Unsealed device packaging 2
Degraded 2
Improper or incorrect procedure or method 2
Sticking 2
Inaccurate synchronization 2
Shelf life exceeded 2
Retraction problem 2
Difficult to position 2
Device damaged prior to use 2
Defective component 2
Malfunction 2
Failure to align 1
Failure to advance 1
Dent in material 1
Labeling, missing 1
Device Issue 1
Out-of-box failure 1
Material perforation 1
User used incorrect product for intended use 1
Reaction 1
Replace 1
Shipping damage or problem 1
Use of Device Issue 1
Noise 1
Displacement 1
Disconnection 1
Material disintegration 1
Component(s), worn 1
Blockage within device or device component 1
Collapse 1
Pitted 1
Nonstandard device or device component 1
Device abrasion from instrument or another object 1
Insulation degradation 1
Lens, repositioning of 1
Failure to separate 1
Defective item 1
Total Device Problems 3479

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

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

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