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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 1
AESCULAP IMPLANT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 2
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 12
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 7
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 3
MATORTHO
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 5
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNI
  SUBSTANTIALLY EQUIVALENT 1
OMNI LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 5
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 14
STELKAST
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECRES SPA
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Insufficient Information 14380
Adverse Event Without Identified Device or Use Problem 5584
Fracture 3752
Loss of or Failure to Bond 3011
Break 2603
Migration or Expulsion of Device 1871
Unstable 1521
Appropriate Term/Code Not Available 1388
Naturally Worn 1289
Loose or Intermittent Connection 906
Failure To Adhere Or Bond 863
Component Missing 811
Device Dislodged or Dislocated 654
Noise, Audible 646
Loss of Osseointegration 592
Loosening of Implant Not Related to Bone-Ingrowth 535
Disassembly 478
Malposition of device 474
Difficult to Insert 470
Migration 355
Detachment of Device or device Component 271
Crack 219
Scratched Material 200
Device Operates Differently Than Expected 199
Fitting Problem 196
Material Integrity Problem 196
Mechanical Problem 167
Device Contamination with Chemical or Other Material 166
Inadequacy of Device Shape and/or Size 165
Unintended Movement 160
Material Deformation 155
Packaging Problem 144
Osseointegration Problem 138
Physical Resistance / Sticking 136
Detachment Of Device Component 130
Degraded 114
Device Slipped 102
Material Erosion 94
Patient Device Interaction Problem 88
Device Packaging Compromised 86
Use of Device Problem 83
Tear, Rip or Hole in Device Packaging 81
Material Discolored 71
Difficult To Position 67
Material Twisted / Bent 67
No Apparent Adverse Event 67
Positioning Problem 66
Corroded 65
Delivered as Unsterile Product 62
Device-Device Incompatibility 59
Metal Shedding Debris 58
Improper or Incorrect Procedure or Method 51
Mechanical Jam 51
Manufacturing, Packaging or Shipping Problem 47
Connection Problem 46
Patient-Device Incompatibility 42
Defective Device 41
Material Separation 39
Device Markings / Labelling Problem 38
Device Contaminated during manufacture or shipping 36
Device Damaged Prior to Use 35
Off-Label Use 34
Peeled / Delaminated 31
Bent 29
Material Fragmentation 28
Difficult to Remove 28
Compatibility Problem 28
Material Disintegration 26
Device Damaged by Another Device 25
Defective Component 23
Residue After Decontamination 23
Failure to Align 22
Pitted 22
Unsealed Device Packaging 22
Misconnection 20
Incorrect Measurement 20
Component Incompatible 20
Screw 20
Device Issue 20
Positioning Failure 19
Device Or Device Fragments Location Unknown 17
Deformation Due to Compressive Stress 16
Incorrect Device Or Component Shipped 16
Contamination / decontamination Problem 15
Material Too Rigid or Stiff 14
Separation Problem 14
Shipping Damage or Problem 13
Incomplete or Missing Packaging 13
Misassembled 13
Device Abrasion From Instrument Or Another Object 12
Biocompatibility 12
Difficult to Open or Remove Packaging Material 12
Delamination 11
Sticking 11
Failure to Osseointegrate 10
Component or Accessory Incompatibility 10
Dent in Material 10
Disconnection 10
Pin 10
Material Distortion 10
Total Device Problems 47190

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems II Jun-26-2015
2 Aesculap, Inc. II Mar-03-2016
3 Arthrex, Inc. II Mar-19-2016
4 Biomet, Inc. III Jun-11-2015
5 Biomet, Inc. II Aug-15-2014
6 ConforMIS, Inc. II Oct-02-2018
7 ConforMIS, Inc. II Feb-13-2018
8 ConforMIS, Inc. II Jan-10-2017
9 ConforMIS, Inc. II Nov-25-2016
10 ConforMIS, Inc. II Oct-21-2015
11 ConforMIS, Inc. II Dec-11-2014
12 Conformis, Inc. II Apr-08-2019
13 Conformis, Inc. II Mar-30-2019
14 DePuy Orthopaedics, Inc. II Aug-29-2018
15 DePuy Orthopaedics, Inc. II Apr-30-2018
16 DePuy Orthopaedics, Inc. II Mar-13-2014
17 DePuy Orthopaedics, Inc. II Feb-24-2014
18 Encore Medical, Lp II Aug-31-2018
19 Encore Medical, Lp II Jan-10-2018
20 Encore Medical, Lp II Oct-20-2017
21 Encore Medical, Lp II Jun-30-2017
22 Encore Medical, Lp II Feb-03-2017
23 Encore Medical, Lp II Dec-14-2016
24 Encore Medical, Lp II Dec-06-2016
25 Encore Medical, Lp II Oct-28-2016
26 Exactech, Inc. II Apr-23-2019
27 Exactech, Inc. II Sep-20-2018
28 Exactech, Inc. II Nov-20-2017
29 Exactech, Inc. II Jun-19-2017
30 Exactech, Inc. II Jan-05-2015
31 Materialise N.V. II Mar-17-2015
32 Materialise USA LLC II Jun-09-2016
33 Materialise USA LLC II Nov-21-2014
34 Medacta Usa Inc II Dec-20-2017
35 Medacta Usa Inc II Jun-26-2015
36 Medtronic Sofamor Danek USA Inc II Mar-21-2017
37 Medtronic Sofamor Danek USA Inc II Aug-23-2016
38 Microport Orthopedics INC. II Mar-06-2015
39 OMNIlife science Inc. II Mar-19-2018
40 Ortho Development Corporation II Jun-26-2015
41 Ortho Development Corporation II Aug-17-2014
42 Ortho Development Corporation II May-13-2014
43 Signal Medical Corporation II Oct-22-2014
44 Signature Orthopedics Pty Limited II Feb-14-2019
45 Smith & Nephew, Inc. II Sep-12-2019
46 Smith & Nephew, Inc. II Mar-22-2019
47 Smith & Nephew, Inc. II Oct-01-2018
48 Smith & Nephew, Inc. II Aug-22-2018
49 Smith & Nephew, Inc. II May-22-2018
50 Smith & Nephew, Inc. II Nov-16-2017
51 Smith & Nephew, Inc. II Jun-12-2017
52 Smith & Nephew, Inc. II Apr-21-2016
53 Smith & Nephew, Inc. II Feb-17-2016
54 Smith & Nephew, Inc. II Jan-04-2016
55 Smith & Nephew, Inc. II Dec-12-2014
56 Stanmore Implants Worldwide Ltd. II May-09-2016
57 Stelkast Co II Jan-14-2015
58 Stryker Howmedica Osteonics Corp. II Aug-09-2016
59 Stryker Howmedica Osteonics Corp. II Dec-02-2015
60 Stryker Howmedica Osteonics Corp. II Nov-09-2015
61 Stryker Howmedica Osteonics Corp. II Aug-10-2015
62 Stryker Howmedica Osteonics Corp. II May-19-2015
63 Stryker Howmedica Osteonics Corp. II May-14-2015
64 United Orthopedic Corporation II Mar-19-2018
65 Zimmer Biomet, Inc. II Sep-12-2019
66 Zimmer Biomet, Inc. II Apr-04-2019
67 Zimmer Biomet, Inc. II Feb-23-2019
68 Zimmer Biomet, Inc. II Dec-18-2018
69 Zimmer Biomet, Inc. II Nov-21-2018
70 Zimmer Biomet, Inc. II Sep-25-2018
71 Zimmer Biomet, Inc. II Jun-04-2018
72 Zimmer Biomet, Inc. II Jun-01-2018
73 Zimmer Biomet, Inc. II Jun-01-2018
74 Zimmer Biomet, Inc. II May-11-2018
75 Zimmer Biomet, Inc. II Mar-14-2018
76 Zimmer Biomet, Inc. II Feb-21-2018
77 Zimmer Biomet, Inc. II Feb-15-2018
78 Zimmer Biomet, Inc. II May-18-2017
79 Zimmer Biomet, Inc. II Mar-27-2017
80 Zimmer Biomet, Inc. II Feb-16-2017
81 Zimmer Biomet, Inc. II Jan-28-2017
82 Zimmer Biomet, Inc. II Oct-18-2016
83 Zimmer Biomet, Inc. II Oct-03-2016
84 Zimmer Biomet, Inc. II Feb-22-2016
85 Zimmer CAS II Dec-16-2014
86 Zimmer Manufacturing B.V. II Apr-06-2016
87 Zimmer Manufacturing B.V. II Mar-12-2016
88 Zimmer Manufacturing B.V. II Jan-05-2016
89 Zimmer Manufacturing B.V. II Dec-18-2015
90 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
91 Zimmer, Inc. II Jul-01-2015
92 Zimmer, Inc. II May-01-2015
93 Zimmer, Inc. II Apr-01-2015
94 Zimmer, Inc. II Feb-03-2015
95 Zimmer, Inc. II Dec-23-2014
96 Zimmer, Inc. II Nov-08-2014
97 Zimmer, Inc. II Oct-23-2014
98 Zimmer, Inc. II Sep-04-2014
99 Zimmer, Inc. II Sep-04-2014
100 Zimmer, Inc. II Aug-26-2014
101 Zimmer, Inc. II Aug-21-2014
102 Zimmer, Inc. II Jun-27-2014
103 Zimmer, Inc. II Mar-20-2014
104 Zimmer, Inc. II Feb-20-2014

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