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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 53
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 24
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 3991
Dislodged or dislocated 2013
Implant, removal of 1897
No code available 1239
Naturally worn 1118
Loss of osseointegration 967
Disassembly 671
Malposition of device 579
Dislocated 562
Unknown (for use when the device problem is not known) 524
Fracture 469
Loose 400
Metal shedding debris 352
Corrosion 338
Break 314
Component(s), worn 298
No Known Device Problem 268
Noise, Audible 231
Migration of device or device component 182
Loose or intermittent connection 181
Other (for use when an appropriate device code cannot be identified) 160
Device remains implanted 154
Loss of or failure to bond 130
Material integrity issue 129
Explanted 115
Fitting problem 102
Mechanical issue 95
Detachment of device component 83
Unstable 66
Slippage of device or device component 66
Device operates differently than expected 63
Component(s), broken 62
Difficult to insert 60
Size incorrect for patient 56
Failure to Adhere or Bond 55
Positioning Issue 51
Manufacturing or shipping issue associated with device 50
Incompatibility problem 35
Degraded 32
Material deformation 30
Packaging issue 27
Tear, rip or hole in device packaging 26
Material separation 23
Use of Device Issue 20
Difficult to remove 19
Osseointegration issue 19
Foreign material present in device 19
Not Applicable 18
Material erosion 18
Sticking 17
Malfunction 16
Patient-device incompatibility 16
Unintended movement 13
Component or accessory incompatibility 12
Material twisted 11
Displacement 11
Material discolored 11
Component incompatible 10
Crack 10
Product quality issue 10
Detachment of device or device component 10
Failure to separate 9
Out-of-box failure 9
Bent 9
Component missing 8
Misassembled by Users 8
Mechanics altered 7
Device packaging compromised 7
Connection issue 6
Component falling 6
Device expiration issue 5
Material fragmentation 5
Improper or incorrect procedure or method 5
Delivered as unsterile product 5
Device markings issue 5
Defective item 5
Mechanical jam 5
Device Issue 4
Nonstandard device or device component 4
Device damaged prior to use 4
Defective component 4
Unsealed device packaging 3
Difficult to position 3
Lens, repositioning of 3
Foreign material 3
Disengaged 3
Residue after decontamination 3
Failure to disconnect 3
Device disinfection or sterilization issue 3
Ambient noise issue 3
Biocompatibility issue 3
Material Protrusion 3
Item contaminated during manufacturing or shipping 2
Scratched material 2
Difficult to open or remove packaging material 2
Drift 2
Entrapment of device or device component 2
Excess flow or overinfusion 2
Device, or device fragments remain in patient 2
Shelf life exceeded 2
Total Device Problems 18693

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 7
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 Encore Medical, Lp II Jul-19-2016
14 Exactech, Inc. II Feb-03-2014
15 Exactech, Inc. III Mar-12-2008
16 Exactech, Inc. II Jun-09-2007
17 Omnilife Science Inc. II Aug-21-2015
18 Orthopedic Alliance LLC II May-24-2013
19 Signal Medical Corporation II Oct-22-2014
20 Smith & Nephew Inc II Dec-26-2013
21 Smith & Nephew Inc II Apr-21-2009
22 Stryker Howmedica Osteonics Corp. II Jul-25-2016
23 Stryker Howmedica Osteonics Corp. II Nov-10-2015
24 Stryker Howmedica Osteonics Corp. II Sep-23-2015
25 Stryker Howmedica Osteonics Corp. II May-19-2015
26 Stryker Howmedica Osteonics Corp. II Mar-02-2010
27 Stryker Howmedica Osteonics Corp. II Dec-14-2007
28 Stryker Howmedica Osteonics Corp. II Dec-14-2007
29 Wright Medical Technology Inc II Oct-31-2012
30 Zimmer Biomet, Inc. II Mar-04-2016
31 Zimmer Biomet, Inc. II Feb-22-2016
32 Zimmer Gmbh II Feb-20-2015
33 Zimmer Inc. II Jun-26-2015
34 Zimmer Inc. II Dec-01-2011
35 Zimmer Inc. II Oct-14-2010
36 Zimmer Inc. II Aug-26-2010
37 Zimmer Inc. II Aug-12-2010
38 Zimmer Inc. II Nov-13-2009
39 Zimmer Inc. II Jul-27-2009
40 Zimmer Inc. II Mar-19-2008
41 Zimmer Manufacturing B.V. II May-16-2016
42 Zimmer Manufacturing B.V. II Mar-12-2016
43 Zimmer Manufacturing B.V. II Dec-24-2014
44 Zimmer Manufacturing B.V. II Dec-17-2014
45 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
46 Zimmer, Inc. II Jul-10-2014
47 Zimmer, Inc. II Jun-20-2014
48 Zimmer, Inc. II Apr-24-2014
49 Zimmer, Inc. II Feb-20-2014
50 Zimmer, Inc. II Oct-25-2013
51 Zimmer, Inc. II Feb-04-2013
52 Zimmer, Inc. II Nov-21-2012

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