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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/polymer, porous uncemented
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product CodeLPH
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
APEX
  SUBSTANTIALLY EQUIVALENT 4
BIOMET
  1
  SUBSTANTIALLY EQUIVALENT 52
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  1
  SUBSTANTIALLY EQUIVALENT 54
ENCORE MEDICAL CORPORATION
  1
  SUBSTANTIALLY EQUIVALENT 24
ESKA IMPLANTS GMBH & CO.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 18
HAYES
  SUBSTANTIALLY EQUIVALENT 3
IMPLEX
  1
  SUBSTANTIALLY EQUIVALENT 9
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 4
JOINT MEDICAL PRODUCTS CORP.
  1
  SUBSTANTIALLY EQUIVALENT 5
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MAYO CLINIC
  SUBSTANTIALLY EQUIVALENT 1
OMNI
  SUBSTANTIALLY EQUIVALENT 10
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 11
OSTEOIMPLANT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 7
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
PORTLAND ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 20
STELKAST
  1
  SUBSTANTIALLY EQUIVALENT 6
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 23
SULZER
  1
  SUBSTANTIALLY EQUIVALENT 9
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 12
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 2
  SUBSTANTIALLY EQUIVALENT 41

Device Problems
No Information 3552
Implant, removal of 1897
Dislodged or dislocated 1795
Naturally worn 1082
No code available 1024
Loss of osseointegration 875
Disassembly 600
Dislocated 562
Unknown (for use when the device problem is not known) 524
Malposition of device 511
Fracture 422
Loose 400
Metal shedding debris 329
Component(s), worn 298
Corrosion 290
Break 267
No Known Device Problem 236
Noise, Audible 203
Loose or intermittent connection 177
Other (for use when an appropriate device code cannot be identified) 160
Device remains implanted 154
Migration of device or device component 151
Loss of or failure to bond 129
Explanted 115
Fitting problem 102
Material integrity issue 85
Detachment of device component 79
Mechanical issue 74
Slippage of device or device component 66
Component(s), broken 62
Device operates differently than expected 62
Unstable 58
Failure to Adhere or Bond 52
Difficult to insert 52
Size incorrect for patient 49
Positioning Issue 39
Manufacturing or shipping issue associated with device 35
Incompatibility problem 33
Tear, rip or hole in device packaging 25
Degraded 22
Material separation 21
Packaging issue 21
Use of Device Issue 20
Not Applicable 18
Sticking 17
Difficult to remove 17
Foreign material present in device 16
Malfunction 16
Material deformation 14
Material erosion 13
Osseointegration issue 12
Patient-device incompatibility 12
Unintended movement 11
Displacement 11
Material discolored 11
Component incompatible 10
Crack 8
Bent 8
Component missing 8
Misassembled by Users 8
Material twisted 8
Mechanics altered 7
Component or accessory incompatibility 6
Connection issue 6
Device packaging compromised 6
Detachment of device or device component 6
Out-of-box failure 6
Product quality issue 6
Component falling 6
Improper or incorrect procedure or method 5
Nonstandard device or device component 4
Device markings issue 4
Failure to separate 4
Defective component 4
Device Issue 4
Mechanical jam 4
Material Protrusion 3
Residue after decontamination 3
Failure to disconnect 3
Device disinfection or sterilization issue 3
Ambient noise issue 3
Delivered as unsterile product 3
Unsealed device packaging 3
Difficult to position 3
Device damaged prior to use 3
Disengaged 3
Device expiration issue 3
Foreign material 3
Material fragmentation 3
Lens, repositioning of 3
Excess flow or overinfusion 2
Drift 2
Entrapment of device or device component 2
Device inoperable 2
Device, or device fragments remain in patient 2
Peeled 2
Difficult to open or remove packaging material 2
Defective item 2
Item contaminated during manufacturing or shipping 2
Scratched material 2
Total Device Problems 17068

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 4 1 3 5 2 5 6 9 8 4
Class III 0 1 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Aug-29-2015
2 Biomet, Inc. III Jun-11-2015
3 Biomet, Inc. II Feb-17-2015
4 Biomet, Inc. II Jun-05-2013
5 Biomet, Inc. II Jun-08-2011
6 Biomet, Inc. II May-26-2010
7 Biomet, Inc. II Oct-27-2007
8 DePuy Orthopaedics, Inc. II May-22-2013
9 DePuy Orthopaedics, Inc. II Dec-20-2012
10 DePuy Orthopaedics, Inc. II Dec-19-2012
11 DePuy Orthopaedics, Inc. II Aug-17-2012
12 Djo Surgical II Mar-04-2014
13 Exactech, Inc. II Feb-03-2014
14 Exactech, Inc. III Mar-12-2008
15 Exactech, Inc. II Jun-09-2007
16 Omnilife Science Inc. II Aug-21-2015
17 Orthopedic Alliance LLC II May-24-2013
18 Signal Medical Corporation II Oct-22-2014
19 Smith & Nephew Inc II Dec-26-2013
20 Smith & Nephew Inc II Apr-21-2009
21 Stryker Howmedica Osteonics Corp. II Nov-10-2015
22 Stryker Howmedica Osteonics Corp. II Sep-23-2015
23 Stryker Howmedica Osteonics Corp. II May-19-2015
24 Stryker Howmedica Osteonics Corp. II Mar-02-2010
25 Stryker Howmedica Osteonics Corp. II Dec-14-2007
26 Stryker Howmedica Osteonics Corp. II Dec-14-2007
27 Wright Medical Technology Inc II Oct-31-2012
28 Zimmer Biomet, Inc. II Mar-04-2016
29 Zimmer Biomet, Inc. II Feb-22-2016
30 Zimmer Gmbh II Feb-20-2015
31 Zimmer Inc. II Jun-26-2015
32 Zimmer Inc. II Dec-01-2011
33 Zimmer Inc. II Oct-14-2010
34 Zimmer Inc. II Aug-26-2010
35 Zimmer Inc. II Aug-12-2010
36 Zimmer Inc. II Nov-13-2009
37 Zimmer Inc. II Jul-27-2009
38 Zimmer Inc. II Mar-19-2008
39 Zimmer Manufacturing B.V. II May-16-2016
40 Zimmer Manufacturing B.V. II Mar-12-2016
41 Zimmer Manufacturing B.V. II Dec-24-2014
42 Zimmer Manufacturing B.V. II Dec-17-2014
43 Zimmer, Inc. II Jul-10-2014
44 Zimmer, Inc. II Jun-20-2014
45 Zimmer, Inc. II Apr-24-2014
46 Zimmer, Inc. II Feb-20-2014
47 Zimmer, Inc. II Oct-25-2013
48 Zimmer, Inc. II Feb-04-2013
49 Zimmer, Inc. II Nov-21-2012

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