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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 13
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 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 6266
Implant, removal of 3473
Loss of or failure to bond 1814
Loose 1747
Naturally worn 1412
Break 1083
Component(s), worn 1027
Fracture 908
No code available 864
Unknown (for use when the device problem is not known) 857
Loose or intermittent connection 710
Failure to Adhere or Bond 689
Explanted 450
Loss of osseointegration 400
Migration of device or device component 379
Difficult to insert 344
Unstable 344
Other (for use when an appropriate device code cannot be identified) 283
Device remains implanted 282
Malposition of device 275
Disassembly 257
No Known Device Problem 253
Fitting problem 228
Dislodged or dislocated 222
Detachment of device component 201
Component missing 186
Material integrity issue 179
Device operates differently than expected 129
Slippage of device or device component 116
Noise, Audible 101
Degraded 96
Size incorrect for patient 88
Crack 81
Tear, rip or hole in device packaging 72
Mechanical issue 60
Device, or device fragments remain in patient 51
Dislocated 44
Component(s), broken 43
Packaging issue 39
Disengaged 37
Osseointegration issue 36
Component incompatible 35
Metal shedding debris 35
Use of Device Issue 34
Patient-device incompatibility 31
Positioning Issue 30
Incompatibility problem 29
Foreign material 29
Material erosion 28
Manufacturing or shipping issue associated with device 27
Foreign material present in device 25
Material discolored 23
Pitted 23
User used incorrect product for intended use 22
Malfunction 22
Device packaging compromised 21
Sticking 21
Scratched material 19
Improper or incorrect procedure or method 18
Device Issue 16
Material deformation 16
Noise 15
Incomplete or missing packaging 14
Device markings issue 14
Mechanical jam 14
Not Applicable 13
Detachment of device or device component 13
Failure to align 13
Material separation 13
Contamination during use 13
Material fragmentation 12
Device damaged prior to use 12
Device or device fragments location unknown 11
Unsealed device packaging 11
Corrosion 11
Mislabeled 9
Delamination 9
Material rigid or stiff 9
Unintended movement 9
Misassembled by Users 9
Item contaminated during manufacturing or shipping 8
Device expiration issue 8
Displacement 8
Material disintegration 8
Component falling 7
Bent 7
Difficult to remove 7
Replace 7
Delivered as unsterile product 7
Device or device component damaged by another device 6
Flaked 6
Difficult to position 5
Misassembled 5
Component or accessory incompatibility 5
Mechanics altered 5
Material Distortion 5
Disinfection or Sterilization Issue at User Location 4
Misapplication 4
Melted 4
Collapse 4
Total Device Problems 26974

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

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