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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
  SUBSTANTIALLY EQUIVALENT 20
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 2
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 18
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 4
DOW
  SUBSTANTIALLY EQUIVALENT 6
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 13
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
HAYES
  SUBSTANTIALLY EQUIVALENT 2
IMPLEX
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
JOINT MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 9
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 3
OMNI
  SUBSTANTIALLY EQUIVALENT 3
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 6
PORTLAND ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 16
STELKAST
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 30
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 4
SULZER
  SUBSTANTIALLY EQUIVALENT 8
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 9
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 16
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 3

Device Problems
Dislodged or dislocated 197
Implant, removal of 179
No Information 177
Unknown (for use when the device problem is not known) 77
Fracture 57
Dislocated 51
Break 46
No Known Device Problem 43
Loose 43
No code available 39
Explanted 36
Loss of osseointegration 26
Loose or intermittent connection 21
Component(s), broken 16
Fitting problem 14
Detachment of device component 13
Other (for use when an appropriate device code cannot be identified) 13
Difficult to insert 11
Loss of or failure to bond 8
Tear, rip or hole in device packaging 8
Migration of device or device component 8
Metal shedding debris 7
Disassembly 6
Naturally worn 5
Malposition of device 5
Device remains implanted 4
Difficult to remove 3
Component incompatible 3
Corrosion 3
Size incorrect for patient 3
Sticking 2
Foreign material present in device 2
Defective component 2
Inaccurate synchronization 2
Unsealed device packaging 2
Packaging issue 2
Component missing 1
Device expiration issue 1
Insulation degradation 1
Mechanical issue 1
Shelf life exceeded 1
Shipping damage or problem 1
Slippage of device or device component 1
Noise, Audible 1
Device markings issue 1
Component(s), worn 1
Displacement 1
Reaction 1
Replace 1
Device damaged prior to use 1
Malfunction 1
Locking mechanism failure 1
Pitted 1
Failure to osseointegrate 1
Noise 1
Labeling, missing 1
Incompatibility problem 1
Osseointegration issue 1
Lens, repositioning of 1
Total Device Problems 1157

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 2 5 2 3 5 1
Class III 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Inc II Aug-12-2011
2 Biomet, Inc. II Apr-23-2012
3 Biomet, Inc. II Mar-02-2012
4 Biomet, Inc. II Jul-14-2009
5 Exactech, Inc. II Feb-05-2013
6 Ortho Development Corporation II Jan-13-2012
7 Ortho Development Corporation II Mar-16-2011
8 Stryker Howmedica Osteonics Corp. II Sep-28-2012
9 Stryker Howmedica Osteonics Corp. II Nov-16-2011
10 Stryker Howmedica Osteonics Corp. II Mar-11-2010
11 Stryker Howmedica Osteonics Corp. II Jan-11-2010
12 Stryker Howmedica Osteonics Corp. III Sep-14-2009
13 Stryker Howmedica Osteonics Corp. II May-21-2009
14 Stryker Howmedica Osteonics Corp. II Jan-26-2009
15 Stryker Howmedica Osteonics Corp. II Jan-26-2009
16 Stryker Howmedica Osteonics Corp. II Oct-31-2008
17 Wright Medical Technology Inc II Jun-07-2007
18 Zimmer Inc. II Jul-27-2009
19 Zimmer Inc. II Nov-21-2008
20 Zimmer, Inc. II Nov-06-2012

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