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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 5100
Dislodged or dislocated 2465
Implant, removal of 1897
No code available 1719
Loss of osseointegration 1229
Naturally worn 1208
Disassembly 808
Malposition of device 708
Fracture 597
Dislocated 562
Unknown (for use when the device problem is not known) 524
Corrosion 472
Metal shedding debris 418
Loose 400
Break 379
No Known Device Problem 330
Noise, Audible 303
Component(s), worn 298
Migration of device or device component 275
Material integrity issue 255
Loose or intermittent connection 191
Other (for use when an appropriate device code cannot be identified) 160
Mechanical issue 156
Device remains implanted 154
Loss of or failure to bond 141
Explanted 115
Fitting problem 105
Detachment of device component 94
Difficult to insert 79
Unstable 78
Device operates differently than expected 68
Positioning Issue 67
Slippage of device or device component 67
Failure to Adhere or Bond 66
Component(s), broken 62
Size incorrect for patient 62
Manufacturing or shipping issue associated with device 62
Material deformation 57
Degraded 57
Packaging issue 40
Incompatibility problem 38
Difficult to remove 38
Material erosion 35
Osseointegration issue 34
Tear, rip or hole in device packaging 31
Material separation 23
Use of Device Issue 23
Not Applicable 20
Foreign material present in device 20
Sticking 17
Crack 17
Malfunction 16
Patient-device incompatibility 16
Failure to separate 16
Unintended movement 15
Device packaging compromised 14
Component or accessory incompatibility 14
Detachment of device or device component 14
Material discolored 13
Bent 13
Component incompatible 12
Mechanical jam 12
Material twisted 11
Component missing 11
Displacement 11
Product quality issue 11
Difficult to position 10
Out-of-box failure 10
Device markings issue 10
Misassembled by Users 8
Mechanics altered 7
Connection issue 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
Failure to osseointegrate 4
Misconnection 4
Foreign material 3
Lens, repositioning of 3
Disengaged 3
Biocompatibility issue 3
Failure to disconnect 3
Device disinfection or sterilization issue 3
Residue after decontamination 3
Scratched material 3
Item contaminated during manufacturing or shipping 3
Material Protrusion 3
Material Distortion 2
Difficult to open or remove packaging material 2
Delamination 2
Material disintegration 2
Total Device Problems 22481

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

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