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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 IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 9
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 1
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY SYNTHES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 6
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 7
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
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 4
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 12
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 7
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 8

MDR Year MDR Reports MDR Events
2015 6874 6874
2016 7574 7574
2017 12254 12254
2018 14029 14029
2019 15002 15002
2020 8298 8298

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 17214 17214
Adverse Event Without Identified Device or Use Problem 12803 12803
Fracture 4905 4905
Loss of or Failure to Bond 4787 4787
Break 3449 3449
Appropriate Term/Code Not Available 2870 2870
Unstable 2673 2673
Loose or Intermittent Connection 2087 2087
Naturally Worn 2074 2074
Migration or Expulsion of Device 1870 1870
Loosening of Implant Not Related to Bone-Ingrowth 1274 1274
Device Dislodged or Dislocated 1150 1150
Noise, Audible 928 928
Component Missing 885 885
Failure To Adhere Or Bond 852 852
Malposition of Device 777 777
Loss of Osseointegration 723 723
Detachment of Device or Device Component 641 641
Migration 607 607
Device Slipped 561 561
Difficult to Insert 523 523
Disassembly 502 502
Device Operates Differently Than Expected 499 499
Crack 345 345
Scratched Material 316 316
Unintended Movement 315 315
Inadequacy of Device Shape and/or Size 310 310
Patient Device Interaction Problem 293 293
Material Deformation 252 252
Use of Device Problem 251 251
Fitting Problem 242 242
Mechanical Problem 207 207
Patient-Device Incompatibility 203 203
Packaging Problem 191 191
Physical Resistance/Sticking 191 191
Material Integrity Problem 187 187
Device Contamination with Chemical or Other Material 164 164
Osseointegration Problem 163 163
Detachment Of Device Component 148 148
Degraded 129 129
Material Twisted/Bent 124 124
Corroded 116 116
Material Erosion 113 113
Positioning Problem 111 111
Device-Device Incompatibility 111 111
Improper or Incorrect Procedure or Method 108 108
Tear, Rip or Hole in Device Packaging 108 108
Screw 106 106
Device Packaging Compromised 97 97
Connection Problem 86 86
Peeled/Delaminated 81 81
Material Discolored 79 79
Defective Device 78 78
Material Separation 75 75
Metal Shedding Debris 74 74
Nonstandard Device 74 74
Positioning Failure 73 73
Contamination 73 73
Difficult To Position 71 71
Delivered as Unsterile Product 70 70
No Apparent Adverse Event 67 67
Device Contaminated During Manufacture or Shipping 66 66
Defective Component 63 63
Device Markings/Labelling Problem 56 56
Microbial Contamination of Device 56 56
Failure to Align 55 55
Mechanical Jam 53 53
Manufacturing, Packaging or Shipping Problem 49 49
Material Fragmentation 47 47
Device Damaged Prior to Use 45 45
Off-Label Use 44 44
Material Too Rigid or Stiff 43 43
Difficult to Remove 38 38
Illegible Information 37 37
Material Disintegration 36 36
Compatibility Problem 33 33
Bent 31 31
Incorrect Measurement 30 30
Pin 28 28
Contamination /Decontamination Problem 27 27
Unsealed Device Packaging 27 27
Device Damaged by Another Device 27 27
Residue After Decontamination 25 25
Component Incompatible 24 24
Bearings 23 23
Sticking 23 23
Product Quality Problem 22 22
Collapse 22 22
Misconnection 21 21
Plate 20 20
Pitted 20 20
Device Issue 19 19
Component Falling 19 19
Incorrect Device Or Component Shipped 19 19
Material Rupture 18 18
Delamination 18 18
Difficult to Open or Remove Packaging Material 18 18
Deformation Due to Compressive Stress 17 17
Leak/Splash 17 17
Mechanics Altered 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 16475 16476
No Code Available 15839 15839
No Information 10212 10212
Unspecified Infection 9002 9002
Injury 4700 4700
No Known Impact Or Consequence To Patient 4437 4438
No Consequences Or Impact To Patient 3958 3958
Swelling 2203 2203
No Patient Involvement 1663 1663
Limited Mobility Of The Implanted Joint 1612 1612
Not Applicable 1561 1561
Bone Fracture(s) 1494 1494
Osteolysis 1453 1453
Loss of Range of Motion 1298 1298
Joint Disorder 1216 1216
Failure of Implant 1020 1020
Adhesion(s) 989 989
Fall 963 963
Edema 796 796
Ambulation Difficulties 753 753
Joint Dislocation 633 634
Reaction 630 630
Discomfort 501 501
Thrombosis 454 454
Inflammation 434 434
Inadequate Osseointegration 424 424
Muscular Rigidity 383 383
Synovitis 383 383
Fibrosis 361 361
Tissue Damage 356 356
Hematoma 341 341
Scar Tissue 311 311
Joint Swelling 290 290
Pulmonary Embolism 281 281
Hypersensitivity/Allergic reaction 273 273
Death 244 244
Impaired Healing 238 238
Wound Dehiscence 234 234
Foreign Body Reaction 214 214
Patient Problem/Medical Problem 188 188
Cyst(s) 177 177
Bacterial Infection 163 163
Necrosis 148 148
Cellulitis 138 138
Damage to Ligament(s) 132 132
Hemorrhage/Bleeding 121 121
Weakness 120 120
Post Operative Wound Infection 117 117
Rash 116 116
Foreign Body In Patient 109 109
Numbness 106 106
Blood Loss 98 98
Burning Sensation 91 91
Rupture 85 85
Ossification 82 82
Scarring 80 80
Sepsis 76 76
Device Embedded In Tissue or Plaque 74 74
Urinary Tract Infection 73 73
Complaint, Ill-Defined 67 67
Embolism 65 65
Fever 65 65
Arthritis 65 65
Aspiration/Inhalation 65 65
Erythema 64 64
Anemia 63 63
Nerve Damage 61 61
Arthralgia 53 53
Alteration In Body Temperature 52 52
Neck Stiffness 51 51
Tingling 47 47
Pneumonia 47 47
Fluid Discharge 46 46
Myocardial Infarction 45 45
Arrhythmia 43 43
Staphylococcus Aureus 43 43
Osteopenia/ Osteoporosis 42 42
Toxicity 41 41
Test Result 38 38
Itching Sensation 34 34
Fatigue 32 32
Skin Irritation 30 30
Low Blood Pressure/ Hypotension 30 30
Muscle Weakness 30 30
Urinary Retention 30 30
Local Reaction 29 29
Chest Pain 29 29
Bruise/Contusion 29 29
Abscess 29 29
Hypoesthesia 27 27
Purulent Discharge 27 27
Nausea 27 27
Peroneal Nerve Palsy 27 27
Skin Discoloration 26 26
Sleep Dysfunction 25 25
Fungal Infection 23 23
Renal Failure 23 23
Disability 22 22
Irritation 21 21
Increased Sensitivity 20 20

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems II Jun-26-2015
2 Aesculap Implant Systems LLC II Mar-13-2020
3 Aesculap, Inc. II Mar-03-2016
4 Arthrex, Inc. II Mar-19-2016
5 Biomet, Inc. II May-28-2020
6 Biomet, Inc. II Apr-03-2020
7 Biomet, Inc. III Jun-11-2015
8 ConforMIS, Inc. II Oct-02-2018
9 ConforMIS, Inc. II Feb-13-2018
10 ConforMIS, Inc. II Jan-10-2017
11 ConforMIS, Inc. II Nov-25-2016
12 ConforMIS, Inc. II Oct-21-2015
13 Conformis, Inc. II Aug-22-2020
14 Conformis, Inc. II Apr-01-2020
15 Conformis, Inc. II Dec-12-2019
16 Conformis, Inc. II Apr-08-2019
17 Conformis, Inc. II Mar-30-2019
18 DePuy Orthopaedics, Inc. II Aug-29-2018
19 DePuy Orthopaedics, Inc. II Apr-30-2018
20 Encore Medical, Lp II Aug-31-2018
21 Encore Medical, Lp II Jan-10-2018
22 Encore Medical, Lp II Oct-20-2017
23 Encore Medical, Lp II Jun-30-2017
24 Encore Medical, Lp II Feb-03-2017
25 Encore Medical, Lp II Dec-14-2016
26 Encore Medical, Lp II Dec-06-2016
27 Encore Medical, Lp II Oct-28-2016
28 Exactech, Inc. II Feb-26-2020
29 Exactech, Inc. II Apr-23-2019
30 Exactech, Inc. II Sep-20-2018
31 Exactech, Inc. II Nov-20-2017
32 Exactech, Inc. II Jun-19-2017
33 Exactech, Inc. II Jan-05-2015
34 Materialise N.V. II Mar-17-2015
35 Materialise USA LLC II Jun-09-2016
36 Medacta Usa Inc II Dec-20-2017
37 Medacta Usa Inc II Jun-26-2015
38 Medtronic Sofamor Danek USA Inc II Mar-21-2017
39 Medtronic Sofamor Danek USA Inc II Aug-23-2016
40 Microport Orthopedics INC. II Mar-06-2015
41 OMNIlife science Inc. II Mar-19-2018
42 Ortho Development Corporation II May-06-2020
43 Ortho Development Corporation II Jun-26-2015
44 Signature Orthopedics Pty Limited II Feb-14-2019
45 Smith & Nephew, Inc. II Aug-08-2020
46 Smith & Nephew, Inc. II Mar-17-2020
47 Smith & Nephew, Inc. II Sep-12-2019
48 Smith & Nephew, Inc. II Mar-22-2019
49 Smith & Nephew, Inc. II Oct-01-2018
50 Smith & Nephew, Inc. II Aug-22-2018
51 Smith & Nephew, Inc. II May-22-2018
52 Smith & Nephew, Inc. II Nov-16-2017
53 Smith & Nephew, Inc. II Jun-12-2017
54 Smith & Nephew, Inc. II Apr-21-2016
55 Smith & Nephew, Inc. II Feb-17-2016
56 Smith & Nephew, Inc. II Jan-04-2016
57 Stanmore Implants Worldwide Ltd. II May-09-2016
58 Stelkast Co II Jan-14-2015
59 Stryker Howmedica Osteonics Corp. II Aug-09-2016
60 Stryker Howmedica Osteonics Corp. II Dec-02-2015
61 Stryker Howmedica Osteonics Corp. II Nov-09-2015
62 Stryker Howmedica Osteonics Corp. II Aug-10-2015
63 Stryker Howmedica Osteonics Corp. II May-19-2015
64 Stryker Howmedica Osteonics Corp. II May-14-2015
65 United Orthopedic Corporation II Mar-19-2018
66 Zimmer Biomet, Inc. II Nov-07-2019
67 Zimmer Biomet, Inc. II Sep-12-2019
68 Zimmer Biomet, Inc. II Apr-04-2019
69 Zimmer Biomet, Inc. II Feb-23-2019
70 Zimmer Biomet, Inc. II Dec-18-2018
71 Zimmer Biomet, Inc. II Nov-21-2018
72 Zimmer Biomet, Inc. II Sep-25-2018
73 Zimmer Biomet, Inc. II Jun-04-2018
74 Zimmer Biomet, Inc. II Jun-01-2018
75 Zimmer Biomet, Inc. II Jun-01-2018
76 Zimmer Biomet, Inc. II May-11-2018
77 Zimmer Biomet, Inc. II Mar-14-2018
78 Zimmer Biomet, Inc. II Feb-21-2018
79 Zimmer Biomet, Inc. II Feb-15-2018
80 Zimmer Biomet, Inc. II May-18-2017
81 Zimmer Biomet, Inc. II Mar-27-2017
82 Zimmer Biomet, Inc. II Feb-16-2017
83 Zimmer Biomet, Inc. II Jan-28-2017
84 Zimmer Biomet, Inc. II Oct-18-2016
85 Zimmer Biomet, Inc. II Oct-03-2016
86 Zimmer Biomet, Inc. II Feb-22-2016
87 Zimmer Manufacturing B.V. II Apr-06-2016
88 Zimmer Manufacturing B.V. II Mar-12-2016
89 Zimmer Manufacturing B.V. II Jan-05-2016
90 Zimmer Manufacturing B.V. II Dec-18-2015
91 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
92 Zimmer, Inc. II Jul-01-2015
93 Zimmer, Inc. II May-01-2015
94 Zimmer, Inc. II Apr-01-2015
95 Zimmer, Inc. II Feb-03-2015
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