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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
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
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 14
EXACTECH, INC.
  8
  SUBSTANTIALLY EQUIVALENT 20
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 36
STELKAST
  SUBSTANTIALLY EQUIVALENT 11
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 7829
Implant, removal of 3472
Loss of or failure to bond 2164
Loose 1747
Naturally worn 1571
Fracture 1557
Break 1369
Component(s), worn 1027
No code available 1026
Unknown (for use when the device problem is not known) 857
Migration of device or device component 764
Failure to Adhere or Bond 736
Loose or intermittent connection 735
Unstable 538
Loss of osseointegration 452
Explanted 450
Difficult to insert 369
Disassembly 359
Malposition of device 330
Component missing 319
No Known Device Problem 316
Dislodged or dislocated 290
Other (for use when an appropriate device code cannot be identified) 283
Device remains implanted 281
Fitting problem 237
Detachment of device component 212
Material integrity issue 193
Noise, Audible 142
Device operates differently than expected 138
Slippage of device or device component 118
Crack 112
Size incorrect for patient 104
Degraded 92
Tear, rip or hole in device packaging 84
Mechanical issue 70
Packaging issue 52
Device, or device fragments remain in patient 51
Dislocated 44
Component(s), broken 43
Positioning Issue 43
Material erosion 40
Component incompatible 39
Metal shedding debris 39
Use of Device Issue 38
Osseointegration issue 38
Disengaged 37
Patient-device incompatibility 34
Incompatibility problem 30
Manufacturing or shipping issue associated with device 29
Foreign material 29
Pitted 28
Device packaging compromised 28
Foreign material present in device 28
Material discolored 27
User used incorrect product for intended use 25
Device markings issue 24
Malfunction 22
Improper or incorrect procedure or method 21
Difficult to position 21
Sticking 20
Material deformation 20
Scratched material 20
Mechanical jam 19
Not Applicable 19
Incomplete or missing packaging 18
Device or device fragments location unknown 17
Device Issue 16
Detachment of device or device component 15
Noise 15
Unsealed device packaging 15
Delivered as unsterile product 14
Material fragmentation 14
Material separation 14
Failure to align 14
Contamination during use 13
Corrosion 12
Device damaged prior to use 12
Unintended movement 12
Item contaminated during manufacturing or shipping 12
Difficult to remove 10
Delamination 10
Connection issue 9
Material rigid or stiff 9
Bent 9
Device expiration issue 9
Mislabeled 9
Misassembled by Users 9
Misassembled 8
Displacement 8
Material disintegration 8
Replace 7
Device or device component damaged by another device 6
Component falling 6
Flaked 6
Material Distortion 6
Incorrect device or component shipped 5
Mechanics altered 5
Misconnection 5
Component or accessory incompatibility 5
Disinfection or Sterilization Issue at User Location 4
Total Device Problems 31617

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 10 7 13 22 6 13 15 20 18 19 7
Class III 1 2 1 0 0 0 0 0 1 0 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 Jan-10-2017
20 ConforMIS, Inc. II Nov-25-2016
21 ConforMIS, Inc. II Oct-21-2015
22 ConforMIS, Inc. II Dec-11-2014
23 Conformis Inc II Aug-17-2012
24 DePuy Orthopaedics, Inc. II Mar-13-2014
25 DePuy Orthopaedics, Inc. II Feb-24-2014
26 DePuy Orthopaedics, Inc. II Nov-27-2013
27 DePuy Orthopaedics, Inc. I Jul-31-2013
28 DePuy Orthopaedics, Inc. II Aug-30-2011
29 Depuy Orthopaedics, Inc. II Aug-21-2009
30 Encore Medical, Lp II Feb-03-2017
31 Encore Medical, Lp II Dec-14-2016
32 Encore Medical, Lp II Dec-06-2016
33 Encore Medical, Lp II Oct-28-2016
34 Encore Medical, Lp II Dec-02-2011
35 Encore Medical, Lp II Aug-22-2010
36 Encore Medical, Lp II Apr-26-2010
37 Encore Medical, Lp II Apr-07-2010
38 Encore Medical, Lp II Feb-24-2010
39 Encore Medical, Lp II Jan-13-2010
40 Encore Medical, Lp II Sep-29-2008
41 Encore Medical, Lp II Aug-20-2008
42 Endotec, Inc. II May-20-2010
43 Exactech, Inc. II Jan-05-2015
44 Exactech, Inc. II Mar-15-2013
45 Exactech, Inc. II Sep-04-2012
46 Exactech, Inc. II Aug-21-2012
47 Exactech, Inc. II Jul-24-2012
48 Exactech, Inc. II Feb-27-2007
49 Materialise N.V. II Mar-17-2015
50 Materialise USA LLC II Jun-09-2016
51 Materialise USA LLC II Nov-21-2014
52 Materialise USA LLC II May-14-2012
53 Medacta Usa Inc II Jun-26-2015
54 Medtronic Sofamor Danek USA Inc II Mar-21-2017
55 Medtronic Sofamor Danek USA Inc II Aug-23-2016
56 Microport Orthopedics INC. II Mar-06-2015
57 Omni Life Science II Sep-13-2012
58 Ortho Development Corporation II Jun-26-2015
59 Ortho Development Corporation II Aug-17-2014
60 Ortho Development Corporation II May-13-2014
61 Ortho Development Corporation II Apr-05-2010
62 Ortho Development Corporation III Sep-09-2009
63 Orthopedic Alliance LLC II May-24-2013
64 Plus Orthopedics USA II Dec-08-2007
65 Plus Orthopedics USA II Dec-08-2007
66 Signal Medical Corporation II Oct-22-2014
67 Smith & Nephew Inc II Dec-04-2013
68 Smith & Nephew Inc II Nov-01-2013
69 Smith & Nephew Inc II Aug-22-2013
70 Smith & Nephew Inc II Aug-23-2009
71 Smith & Nephew, Inc. II Apr-21-2016
72 Smith & Nephew, Inc. II Feb-17-2016
73 Smith & Nephew, Inc. II Jan-04-2016
74 Smith & Nephew, Inc. II Dec-12-2014
75 Stanmore Implants Worldwide Ltd. II May-09-2016
76 Stelkast Co II Jan-14-2015
77 Stelkast Co II Sep-03-2013
78 Stelkast Co II Nov-25-2008
79 Stelkast Co III Jan-23-2008
80 Stryker Howmedica Osteonics Corp. II Aug-09-2016
81 Stryker Howmedica Osteonics Corp. II Dec-02-2015
82 Stryker Howmedica Osteonics Corp. II Nov-09-2015
83 Stryker Howmedica Osteonics Corp. II Aug-10-2015
84 Stryker Howmedica Osteonics Corp. II May-19-2015
85 Stryker Howmedica Osteonics Corp. II May-14-2015
86 Stryker Howmedica Osteonics Corp. II May-23-2013
87 Stryker Howmedica Osteonics Corp. II Apr-05-2013
88 Stryker Howmedica Osteonics Corp. II Mar-16-2011
89 Stryker Howmedica Osteonics Corp. II Feb-11-2011
90 Stryker Howmedica Osteonics Corp. II Oct-06-2010
91 Stryker Howmedica Osteonics Corp. II Aug-31-2010
92 Stryker Howmedica Osteonics Corp. II Mar-16-2010
93 Stryker Howmedica Osteonics Corp. II Mar-02-2010
94 Stryker Howmedica Osteonics Corp. II Feb-19-2010
95 Stryker Howmedica Osteonics Corp. II Feb-01-2010
96 Stryker Howmedica Osteonics Corp. II Dec-01-2009
97 Stryker Howmedica Osteonics Corp. II Jul-23-2009
98 Stryker Howmedica Osteonics Corp. II Jul-15-2009
99 Stryker Howmedica Osteonics Corp. II Jul-07-2009
100 Stryker Howmedica Osteonics Corp. II Mar-03-2009
101 Stryker Howmedica Osteonics Corp. II Jan-26-2009
102 Stryker Howmedica Osteonics Corp. II Sep-16-2008
103 Stryker Howmedica Osteonics Corp. III Jul-16-2008
104 Stryker Howmedica Osteonics Corp. II Dec-11-2007
105 Stryker Howmedica Osteonics Corp. II Sep-25-2007
106 Stryker Howmedica Osteonics Corp. III Sep-21-2007
107 Stryker Howmedica Osteonics Corp. II Feb-08-2007
108 Wright Medical Technology Inc II May-21-2010
109 Wright Medical Technology Inc II Mar-31-2010
110 Zimmer Biomet, Inc. II May-18-2017
111 Zimmer Biomet, Inc. II Mar-27-2017
112 Zimmer Biomet, Inc. II Feb-16-2017
113 Zimmer Biomet, Inc. II Jan-28-2017
114 Zimmer Biomet, Inc. II Oct-18-2016
115 Zimmer Biomet, Inc. II Oct-03-2016
116 Zimmer Biomet, Inc. II Feb-22-2016
117 Zimmer CAS II Dec-16-2014
118 Zimmer Inc. II May-14-2012
119 Zimmer Inc. II Jan-25-2012
120 Zimmer Inc. II Dec-02-2010
121 Zimmer Inc. II Oct-21-2010
122 Zimmer Inc. II Sep-20-2010
123 Zimmer Inc. II Sep-13-2010
124 Zimmer Inc. II Mar-10-2010
125 Zimmer Inc. II Mar-02-2010
126 Zimmer Inc. II Dec-14-2009
127 Zimmer Inc. II Nov-13-2009
128 Zimmer Inc. II Jun-30-2009
129 Zimmer Inc. II Jun-26-2009
130 Zimmer Inc. II Jan-09-2009
131 Zimmer Inc. II Mar-28-2007
132 Zimmer Manufacturing B.V. II Apr-06-2016
133 Zimmer Manufacturing B.V. II Mar-12-2016
134 Zimmer Manufacturing B.V. II Jan-05-2016
135 Zimmer Manufacturing B.V. II Dec-18-2015
136 Zimmer, Inc. II Jul-01-2015
137 Zimmer, Inc. II May-01-2015
138 Zimmer, Inc. II Apr-01-2015
139 Zimmer, Inc. II Feb-03-2015
140 Zimmer, Inc. II Dec-23-2014
141 Zimmer, Inc. II Nov-08-2014
142 Zimmer, Inc. II Oct-23-2014
143 Zimmer, Inc. II Sep-04-2014
144 Zimmer, Inc. II Sep-04-2014
145 Zimmer, Inc. II Aug-26-2014
146 Zimmer, Inc. II Aug-21-2014
147 Zimmer, Inc. II Jun-27-2014
148 Zimmer, Inc. II Mar-20-2014
149 Zimmer, Inc. II Feb-20-2014
150 Zimmer, Inc. II Dec-27-2013
151 Zimmer, Inc. II Dec-11-2013
152 Zimmer, Inc. II Oct-25-2013
153 Zimmer, Inc. II Aug-22-2013
154 Zimmer, Inc. II Dec-18-2012
155 Zimmer, Inc. II Nov-26-2012
156 Zimmer, Inc. II Sep-28-2012

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