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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 18

Device Problems
No Information 787
Dislodged or dislocated 567
No code available 189
Implant, removal of 179
Fracture 143
Break 103
No Known Device Problem 100
Unknown (for use when the device problem is not known) 77
Loose or intermittent connection 69
Dislocated 51
Loss of osseointegration 45
Loose 43
Explanted 36
Difficult to insert 36
Metal shedding debris 34
Fitting problem 32
Detachment of device component 29
Failure to Adhere or Bond 28
Migration of device or device component 27
Noise, Audible 26
Tear, rip or hole in device packaging 24
Naturally worn 21
Malposition of device 21
Slippage of device or device component 17
Component(s), broken 16
Disassembly 16
Material erosion 14
Mechanical issue 13
Other (for use when an appropriate device code cannot be identified) 13
Material integrity issue 13
Device operates differently than expected 12
Size incorrect for patient 12
Loss of or failure to bond 12
Corrosion 11
Unstable 11
Component missing 10
Difficult to remove 10
Foreign material present in device 10
Item contaminated during manufacturing or shipping 10
Osseointegration issue 8
Packaging issue 8
Positioning Issue 7
Device markings issue 7
Patient-device incompatibility 7
Incompatibility problem 6
Material discolored 6
Device-device incompatibility 5
Device remains implanted 4
Material separation 3
Failure to osseointegrate 3
Crack 3
Component incompatible 3
Material Protrusion 3
Mechanics altered 3
Not Applicable 3
Scratched material 2
Detachment of device or device component 2
Material fragmentation 2
Delivered as unsterile product 2
Unsealed device packaging 2
Degraded 2
Device expiration issue 2
Improper or incorrect procedure or method 2
Shelf life exceeded 2
Retraction problem 2
Sticking 2
Inaccurate synchronization 2
Device damaged prior to use 2
Defective component 2
Malfunction 2
Failure to disconnect 2
Failure to separate 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
Out-of-box failure 1
Device Issue 1
Use of Device Issue 1
Shipping damage or problem 1
Noise 1
Material perforation 1
Displacement 1
Disconnection 1
Component(s), worn 1
Blockage within device or device component 1
Collapse 1
Pitted 1
Difficult to position 1
User used incorrect product for intended use 1
Reaction 1
Replace 1
Insulation degradation 1
Lens, repositioning of 1
Device abrasion from instrument or another object 1
Device Contamination with biological material 1
Human-Device Interface Issue 1
Therapeutic or diagnostic output failure 1
Total Device Problems 3007

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

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