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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 4547
Dislodged or dislocated 2211
Implant, removal of 1897
No code available 1555
Naturally worn 1166
Loss of osseointegration 1100
Disassembly 735
Malposition of device 638
Dislocated 562
Fracture 532
Unknown (for use when the device problem is not known) 524
Corrosion 412
Metal shedding debris 406
Loose 400
Break 345
Component(s), worn 298
No Known Device Problem 296
Noise, Audible 275
Migration of device or device component 217
Loose or intermittent connection 186
Material integrity issue 183
Other (for use when an appropriate device code cannot be identified) 160
Device remains implanted 154
Loss of or failure to bond 142
Mechanical issue 122
Explanted 115
Fitting problem 103
Detachment of device component 88
Unstable 71
Difficult to insert 69
Device operates differently than expected 69
Slippage of device or device component 67
Failure to Adhere or Bond 63
Component(s), broken 62
Size incorrect for patient 60
Positioning Issue 59
Manufacturing or shipping issue associated with device 57
Degraded 47
Material deformation 41
Incompatibility problem 35
Packaging issue 30
Tear, rip or hole in device packaging 28
Osseointegration issue 27
Difficult to remove 27
Material separation 23
Material erosion 22
Use of Device Issue 21
Not Applicable 20
Foreign material present in device 19
Sticking 17
Patient-device incompatibility 16
Malfunction 16
Unintended movement 14
Component or accessory incompatibility 13
Material discolored 13
Crack 12
Failure to separate 12
Detachment of device or device component 11
Material twisted 11
Bent 11
Displacement 11
Product quality issue 11
Component incompatible 10
Component missing 10
Out-of-box failure 10
Mechanical jam 8
Misassembled by Users 8
Mechanics altered 7
Device packaging compromised 7
Device markings issue 7
Connection issue 6
Component falling 6
Material fragmentation 6
Difficult to position 6
Delivered as unsterile product 5
Improper or incorrect procedure or method 5
Device expiration issue 5
Defective item 5
Device Issue 5
Device damaged prior to use 5
Defective component 4
Nonstandard device or device component 4
Unsealed device packaging 4
Disengaged 3
Foreign material 3
Lens, repositioning of 3
Residue after decontamination 3
Ambient noise issue 3
Biocompatibility issue 3
Failure to disconnect 3
Device disinfection or sterilization issue 3
Material Protrusion 3
Item contaminated during manufacturing or shipping 2
Difficult to open or remove packaging material 2
Scratched material 2
Excess flow or overinfusion 2
Drift 2
Entrapment of device or device component 2
Peeled 2
User used incorrect product for intended use 2
Total Device Problems 20630

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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