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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 17

Device Problems
No Information 663
Dislodged or dislocated 498
Implant, removal of 179
No code available 164
Fracture 130
Break 98
No Known Device Problem 90
Unknown (for use when the device problem is not known) 77
Loose or intermittent connection 64
Dislocated 51
Loose 43
Loss of osseointegration 42
Explanted 36
Fitting problem 31
Difficult to insert 28
Failure to Adhere or Bond 27
Detachment of device component 27
Metal shedding debris 27
Noise, Audible 24
Tear, rip or hole in device packaging 22
Migration of device or device component 22
Malposition of device 18
Slippage of device or device component 17
Naturally worn 17
Component(s), broken 16
Other (for use when an appropriate device code cannot be identified) 13
Disassembly 12
Device operates differently than expected 12
Material integrity issue 12
Loss of or failure to bond 11
Size incorrect for patient 11
Unstable 11
Component missing 10
Difficult to remove 10
Mechanical issue 10
Corrosion 9
Foreign material present in device 9
Item contaminated during manufacturing or shipping 9
Packaging issue 7
Positioning Issue 7
Patient-device incompatibility 7
Material discolored 6
Material erosion 5
Device markings issue 5
Incompatibility problem 4
Device remains implanted 4
Material separation 3
Failure to osseointegrate 3
Crack 3
Component incompatible 3
Material Protrusion 3
Mechanics altered 3
Osseointegration issue 3
Scratched material 2
Device-device incompatibility 2
Not Applicable 2
Unsealed device packaging 2
Degraded 2
Device expiration issue 2
Improper or incorrect procedure or method 2
Device damaged prior to use 2
Defective component 2
Shelf life exceeded 2
Sticking 2
Inaccurate synchronization 2
Failure to disconnect 2
Malfunction 2
Failure to align 1
Failure to advance 1
Dent in material 1
Labeling, missing 1
Out-of-box failure 1
Device Issue 1
Failure to separate 1
Locking mechanism failure 1
Detachment of device or device component 1
Device Contamination with biological material 1
Shipping damage or problem 1
Replace 1
Noise 1
Displacement 1
Disconnection 1
Component(s), worn 1
Blockage within device or device component 1
Collapse 1
Pitted 1
User used incorrect product for intended use 1
Reaction 1
Delivered as unsterile product 1
Insulation degradation 1
Lens, repositioning of 1
Material fragmentation 1
Device abrasion from instrument or another object 1
Human-Device Interface Issue 1
Therapeutic or diagnostic output failure 1
Total Device Problems 2672

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 2
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-21-2014
9 Exactech, Inc. II Feb-05-2013
10 Omnilife Science Inc. II Jul-14-2015
11 Omnilife Science Inc. II Aug-15-2014
12 Ortho Development Corporation II Jan-13-2012
13 Ortho Development Corporation II Mar-16-2011
14 Orthopedic Alliance LLC II May-24-2013
15 Stryker Howmedica Osteonics Corp. II Sep-28-2012
16 Stryker Howmedica Osteonics Corp. II Nov-16-2011
17 Stryker Howmedica Osteonics Corp. II Mar-11-2010
18 Stryker Howmedica Osteonics Corp. II Jan-11-2010
19 Stryker Howmedica Osteonics Corp. III Sep-14-2009
20 Stryker Howmedica Osteonics Corp. II May-21-2009
21 Stryker Howmedica Osteonics Corp. II Jan-26-2009
22 Stryker Howmedica Osteonics Corp. II Jan-26-2009
23 Stryker Howmedica Osteonics Corp. II Oct-31-2008
24 Wright Medical Technology Inc II Jun-07-2007
25 Zimmer Gmbh II Feb-20-2015
26 Zimmer Inc. II Jul-27-2009
27 Zimmer Inc. II Nov-21-2008
28 Zimmer, Inc. II Feb-27-2015
29 Zimmer, Inc. II Nov-06-2012

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