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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 4815
Dislodged or dislocated 2326
Implant, removal of 1897
No code available 1644
Naturally worn 1191
Loss of osseointegration 1138
Disassembly 768
Malposition of device 668
Fracture 566
Dislocated 562
Unknown (for use when the device problem is not known) 524
Corrosion 441
Metal shedding debris 417
Loose 400
Break 359
No Known Device Problem 315
Component(s), worn 298
Noise, Audible 292
Migration of device or device component 241
Material integrity issue 217
Loose or intermittent connection 190
Other (for use when an appropriate device code cannot be identified) 160
Device remains implanted 154
Loss of or failure to bond 144
Mechanical issue 142
Explanted 115
Fitting problem 104
Detachment of device component 92
Difficult to insert 74
Unstable 74
Device operates differently than expected 69
Slippage of device or device component 67
Failure to Adhere or Bond 64
Positioning Issue 64
Component(s), broken 62
Size incorrect for patient 62
Manufacturing or shipping issue associated with device 59
Degraded 51
Material deformation 46
Incompatibility problem 37
Difficult to remove 33
Osseointegration issue 32
Packaging issue 31
Tear, rip or hole in device packaging 28
Material erosion 24
Material separation 23
Use of Device Issue 22
Not Applicable 21
Foreign material present in device 20
Sticking 17
Patient-device incompatibility 16
Malfunction 16
Crack 15
Failure to separate 14
Unintended movement 14
Component or accessory incompatibility 13
Material discolored 13
Component incompatible 12
Bent 12
Detachment of device or device component 12
Component missing 11
Material twisted 11
Displacement 11
Product quality issue 11
Mechanical jam 10
Device packaging compromised 10
Out-of-box failure 10
Device markings issue 9
Misassembled by Users 8
Mechanics altered 7
Connection issue 7
Difficult to position 7
Material fragmentation 6
Component falling 6
Device expiration issue 5
Nonstandard device or device component 5
Delivered as unsterile product 5
Unsealed device packaging 5
Improper or incorrect procedure or method 5
Defective item 5
Device damaged prior to use 5
Device Issue 5
Defective component 4
Ambient noise issue 4
Biocompatibility issue 3
Failure to disconnect 3
Residue after decontamination 3
Scratched material 3
Device disinfection or sterilization issue 3
Material Protrusion 3
Disengaged 3
Foreign material 3
Lens, repositioning of 3
Excess flow or overinfusion 2
Material disintegration 2
Drift 2
Entrapment of device or device component 2
Failure to osseointegrate 2
Device inoperable 2
Shelf life exceeded 2
Total Device Problems 21510

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 4 1 3 5 2 5 6 9 8 7 2
Class III 0 1 0 0 0 0 0 0 1 0 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 Jan-17-2017
15 Exactech, Inc. II Feb-03-2014
16 Exactech, Inc. III Mar-12-2008
17 Exactech, Inc. II Jun-09-2007
18 Omnilife Science Inc. II Aug-21-2015
19 Orthopedic Alliance LLC II May-24-2013
20 Signal Medical Corporation II Oct-22-2014
21 Smith & Nephew Inc II Dec-26-2013
22 Smith & Nephew Inc II Apr-21-2009
23 Stryker Howmedica Osteonics Corp. II Jul-25-2016
24 Stryker Howmedica Osteonics Corp. II Nov-10-2015
25 Stryker Howmedica Osteonics Corp. II Sep-23-2015
26 Stryker Howmedica Osteonics Corp. II May-19-2015
27 Stryker Howmedica Osteonics Corp. II Mar-02-2010
28 Stryker Howmedica Osteonics Corp. II Dec-14-2007
29 Stryker Howmedica Osteonics Corp. II Dec-14-2007
30 Wright Medical Technology Inc II Oct-31-2012
31 Zimmer Biomet, Inc. II Jan-13-2017
32 Zimmer Biomet, Inc. II Mar-04-2016
33 Zimmer Biomet, Inc. II Feb-22-2016
34 Zimmer Gmbh II Feb-20-2015
35 Zimmer Inc. II Jun-26-2015
36 Zimmer Inc. II Dec-01-2011
37 Zimmer Inc. II Oct-14-2010
38 Zimmer Inc. II Aug-26-2010
39 Zimmer Inc. II Aug-12-2010
40 Zimmer Inc. II Nov-13-2009
41 Zimmer Inc. II Jul-27-2009
42 Zimmer Inc. II Mar-19-2008
43 Zimmer Manufacturing B.V. II May-16-2016
44 Zimmer Manufacturing B.V. II Mar-12-2016
45 Zimmer Manufacturing B.V. II Dec-24-2014
46 Zimmer Manufacturing B.V. II Dec-17-2014
47 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
48 Zimmer, Inc. II Jul-10-2014
49 Zimmer, Inc. II Jun-20-2014
50 Zimmer, Inc. II Apr-24-2014
51 Zimmer, Inc. II Feb-20-2014
52 Zimmer, Inc. II Oct-25-2013
53 Zimmer, Inc. II Feb-04-2013
54 Zimmer, Inc. II Nov-21-2012

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