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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Description Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Product CodeJWH
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 11
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIOMET
  4
  SUBSTANTIALLY EQUIVALENT 49
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 2
CENTERPULSE ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 23
DEPUY INTL., LTD.
  13
  SUBSTANTIALLY EQUIVALENT 31
DJ ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
DOW
  12
  SUBSTANTIALLY EQUIVALENT 12
ENCORE MEDICAL CORPORATION
  6
  SUBSTANTIALLY EQUIVALENT 12
EXACTECH, INC.
  8
  SUBSTANTIALLY EQUIVALENT 19
HAYES
  SUBSTANTIALLY EQUIVALENT 2
IMPLEX
  2
  SUBSTANTIALLY EQUIVALENT 15
JOHNSON & JOHNSON
  7
  SUBSTANTIALLY EQUIVALENT 8
JOINT MEDICAL PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 2
  5
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 8
OMNI
  SUBSTANTIALLY EQUIVALENT 9
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 10
ORTHOPEDIC SYSTEMS, INC.
  1
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 6
SMITH & NEPHEW, INC.
  1
  SUBSTANTIALLY EQUIVALENT 33
STELKAST
  SUBSTANTIALLY EQUIVALENT 10
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 33
SULZER
  1
  SUBSTANTIALLY EQUIVALENT 8
TORNIER
  SUBSTANTIALLY EQUIVALENT 3
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  2
  SUBSTANTIALLY EQUIVALENT 18
ZIMMER, INC.
  5
  SUBSTANTIALLY EQUIVALENT 35

Device Problems
No Information 5615
Implant, removal of 3472
Loose 1747
Loss of or failure to bond 1637
Naturally worn 1337
Component(s), worn 1027
Unknown (for use when the device problem is not known) 857
Break 832
No code available 796
Fracture 747
Loose or intermittent connection 702
Failure to Adhere or Bond 595
Explanted 450
Loss of osseointegration 367
Migration of device or device component 326
Difficult to insert 324
Other (for use when an appropriate device code cannot be identified) 283
Unstable 281
Device remains implanted 280
Malposition of device 257
Disassembly 223
Fitting problem 222
No Known Device Problem 213
Dislodged or dislocated 207
Detachment of device component 185
Component missing 144
Material integrity issue 132
Device operates differently than expected 126
Slippage of device or device component 116
Noise, Audible 85
Size incorrect for patient 70
Tear, rip or hole in device packaging 70
Crack 68
Degraded 56
Device, or device fragments remain in patient 51
Mechanical issue 50
Dislocated 44
Component(s), broken 43
Disengaged 37
Component incompatible 34
Metal shedding debris 34
Packaging issue 32
Patient-device incompatibility 31
Use of Device Issue 30
Osseointegration issue 30
Foreign material 28
Material erosion 26
Manufacturing or shipping issue associated with device 26
Positioning Issue 23
Foreign material present in device 22
Malfunction 22
Pitted 22
User used incorrect product for intended use 21
Incompatibility problem 21
Sticking 19
Material discolored 19
Improper or incorrect procedure or method 17
Device packaging compromised 17
Noise 15
Incomplete or missing packaging 13
Device Issue 13
Material separation 13
Failure to align 13
Contamination during use 13
Mechanical jam 13
Not Applicable 12
Detachment of device or device component 12
Material deformation 11
Device damaged prior to use 11
Device markings issue 10
Corrosion 10
Unsealed device packaging 10
Material fragmentation 10
Mislabeled 9
Material rigid or stiff 9
Device expiration issue 8
Displacement 8
Item contaminated during manufacturing or shipping 8
Unintended movement 8
Misassembled by Users 7
Component falling 7
Difficult to remove 7
Replace 7
Device or device fragments location unknown 7
Delamination 6
Device or device component damaged by another device 6
Material disintegration 6
Flaked 6
Bent 6
Delivered as unsterile product 5
Mechanics altered 5
Scratched material 4
Material Distortion 4
Collapse 4
Melted 4
Misapplication 4
Misassembled 4
Nonstandard device or device component 3
Difficult to open or remove packaging material 3
Connection issue 3
Total Device Problems 24885

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 0 0 0
Class II 10 7 13 22 6 13 15 20 18 12
Class III 1 2 1 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems II Jun-26-2015
2 Aesculap, Inc. II Mar-03-2016
3 Aesculap, Inc. II Dec-13-2013
4 Arthrex, Inc. II Mar-19-2016
5 Biomet, Inc. III Jun-11-2015
6 Biomet, Inc. II Aug-15-2014
7 Biomet, Inc. II Dec-13-2013
8 Biomet, Inc. II Mar-02-2012
9 Biomet, Inc. II Jan-11-2012
10 Biomet, Inc. II Aug-04-2011
11 Biomet, Inc. II Apr-28-2011
12 Biomet, Inc. II Aug-10-2010
13 Biomet, Inc. II Nov-21-2008
14 Biomet, Inc. II Jul-25-2008
15 Biomet, Inc. II Jan-31-2008
16 Biomet, Inc. II Dec-05-2007
17 Biomet, Inc. II Nov-24-2007
18 Biomet, Inc. II Oct-31-2007
19 ConforMIS, Inc. II Oct-21-2015
20 ConforMIS, Inc. II Dec-11-2014
21 Conformis Inc II Aug-17-2012
22 DePuy Orthopaedics, Inc. II Mar-13-2014
23 DePuy Orthopaedics, Inc. II Feb-24-2014
24 DePuy Orthopaedics, Inc. II Nov-27-2013
25 DePuy Orthopaedics, Inc. I Jul-31-2013
26 DePuy Orthopaedics, Inc. II Aug-30-2011
27 Depuy Orthopaedics, Inc. II Aug-21-2009
28 Encore Medical, Lp II Dec-02-2011
29 Encore Medical, Lp II Aug-22-2010
30 Encore Medical, Lp II Apr-26-2010
31 Encore Medical, Lp II Apr-07-2010
32 Encore Medical, Lp II Feb-24-2010
33 Encore Medical, Lp II Jan-13-2010
34 Encore Medical, Lp II Sep-29-2008
35 Encore Medical, Lp II Aug-20-2008
36 Endotec, Inc. II May-20-2010
37 Exactech, Inc. II Jan-05-2015
38 Exactech, Inc. II Mar-15-2013
39 Exactech, Inc. II Sep-04-2012
40 Exactech, Inc. II Aug-21-2012
41 Exactech, Inc. II Jul-24-2012
42 Exactech, Inc. II Feb-27-2007
43 Materialise N.V. II Mar-17-2015
44 Materialise USA LLC II Jun-09-2016
45 Materialise USA LLC II Nov-21-2014
46 Materialise USA LLC II May-14-2012
47 Medacta Usa Inc II Jun-26-2015
48 Microport Orthopedics INC. II Mar-06-2015
49 Omni Life Science II Sep-13-2012
50 Ortho Development Corporation II Jun-26-2015
51 Ortho Development Corporation II Aug-17-2014
52 Ortho Development Corporation II May-13-2014
53 Ortho Development Corporation II Apr-05-2010
54 Ortho Development Corporation III Sep-09-2009
55 Orthopedic Alliance LLC II May-24-2013
56 Plus Orthopedics USA II Dec-08-2007
57 Plus Orthopedics USA II Dec-08-2007
58 Signal Medical Corporation II Oct-22-2014
59 Smith & Nephew Inc II Dec-04-2013
60 Smith & Nephew Inc II Nov-01-2013
61 Smith & Nephew Inc II Aug-22-2013
62 Smith & Nephew Inc II Aug-23-2009
63 Smith & Nephew, Inc. II Apr-21-2016
64 Smith & Nephew, Inc. II Feb-17-2016
65 Smith & Nephew, Inc. II Jan-04-2016
66 Smith & Nephew, Inc. II Dec-12-2014
67 Stanmore Implants Worldwide Ltd. II May-09-2016
68 Stelkast Co II Jan-14-2015
69 Stelkast Co II Sep-03-2013
70 Stelkast Co II Nov-25-2008
71 Stelkast Co III Jan-23-2008
72 Stryker Howmedica Osteonics Corp. II Aug-09-2016
73 Stryker Howmedica Osteonics Corp. II Dec-02-2015
74 Stryker Howmedica Osteonics Corp. II Nov-09-2015
75 Stryker Howmedica Osteonics Corp. II Aug-10-2015
76 Stryker Howmedica Osteonics Corp. II May-19-2015
77 Stryker Howmedica Osteonics Corp. II May-14-2015
78 Stryker Howmedica Osteonics Corp. II May-23-2013
79 Stryker Howmedica Osteonics Corp. II Apr-05-2013
80 Stryker Howmedica Osteonics Corp. II Mar-16-2011
81 Stryker Howmedica Osteonics Corp. II Feb-11-2011
82 Stryker Howmedica Osteonics Corp. II Oct-06-2010
83 Stryker Howmedica Osteonics Corp. II Aug-31-2010
84 Stryker Howmedica Osteonics Corp. II Mar-16-2010
85 Stryker Howmedica Osteonics Corp. II Mar-02-2010
86 Stryker Howmedica Osteonics Corp. II Feb-19-2010
87 Stryker Howmedica Osteonics Corp. II Feb-01-2010
88 Stryker Howmedica Osteonics Corp. II Dec-01-2009
89 Stryker Howmedica Osteonics Corp. II Jul-23-2009
90 Stryker Howmedica Osteonics Corp. II Jul-15-2009
91 Stryker Howmedica Osteonics Corp. II Jul-07-2009
92 Stryker Howmedica Osteonics Corp. II Mar-03-2009
93 Stryker Howmedica Osteonics Corp. II Jan-26-2009
94 Stryker Howmedica Osteonics Corp. II Sep-16-2008
95 Stryker Howmedica Osteonics Corp. III Jul-16-2008
96 Stryker Howmedica Osteonics Corp. II Dec-11-2007
97 Stryker Howmedica Osteonics Corp. II Sep-25-2007
98 Stryker Howmedica Osteonics Corp. III Sep-21-2007
99 Stryker Howmedica Osteonics Corp. II Feb-08-2007
100 Wright Medical Technology Inc II May-21-2010
101 Wright Medical Technology Inc II Mar-31-2010
102 Zimmer Biomet, Inc. II Feb-22-2016
103 Zimmer CAS II Dec-16-2014
104 Zimmer Inc. II May-14-2012
105 Zimmer Inc. II Jan-25-2012
106 Zimmer Inc. II Dec-02-2010
107 Zimmer Inc. II Oct-21-2010
108 Zimmer Inc. II Sep-20-2010
109 Zimmer Inc. II Sep-13-2010
110 Zimmer Inc. II Mar-10-2010
111 Zimmer Inc. II Mar-02-2010
112 Zimmer Inc. II Dec-14-2009
113 Zimmer Inc. II Nov-13-2009
114 Zimmer Inc. II Jun-30-2009
115 Zimmer Inc. II Jun-26-2009
116 Zimmer Inc. II Jan-09-2009
117 Zimmer Inc. II Mar-28-2007
118 Zimmer Manufacturing B.V. II Apr-06-2016
119 Zimmer Manufacturing B.V. II Mar-12-2016
120 Zimmer Manufacturing B.V. II Jan-05-2016
121 Zimmer Manufacturing B.V. II Dec-18-2015
122 Zimmer, Inc. II Jul-01-2015
123 Zimmer, Inc. II May-01-2015
124 Zimmer, Inc. II Apr-01-2015
125 Zimmer, Inc. II Feb-03-2015
126 Zimmer, Inc. II Dec-23-2014
127 Zimmer, Inc. II Nov-08-2014
128 Zimmer, Inc. II Oct-23-2014
129 Zimmer, Inc. II Sep-04-2014
130 Zimmer, Inc. II Sep-04-2014
131 Zimmer, Inc. II Aug-26-2014
132 Zimmer, Inc. II Aug-21-2014
133 Zimmer, Inc. II Jun-27-2014
134 Zimmer, Inc. II Mar-20-2014
135 Zimmer, Inc. II Feb-20-2014
136 Zimmer, Inc. II Dec-27-2013
137 Zimmer, Inc. II Dec-11-2013
138 Zimmer, Inc. II Oct-25-2013
139 Zimmer, Inc. II Aug-22-2013
140 Zimmer, Inc. II Dec-18-2012
141 Zimmer, Inc. II Nov-26-2012
142 Zimmer, Inc. II Sep-28-2012

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