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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
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 2
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 9
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 5
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 5
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 2
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 8
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 3
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 9
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 5
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 8

MDR Year MDR Reports MDR Events
2016 7584 7584
2017 12262 12262
2018 14032 14032
2019 14999 14999
2020 12605 12605
2021 2546 2546

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15516 15516
Insufficient Information 14891 14891
Fracture 5300 5300
Loss of or Failure to Bond 4683 4683
Break 3565 3565
Appropriate Term/Code Not Available 2854 2854
Unstable 2589 2589
Naturally Worn 1877 1877
Loose or Intermittent Connection 1847 1847
Loosening of Implant Not Related to Bone-Ingrowth 1809 1809
Migration or Expulsion of Device 1753 1753
Device Dislodged or Dislocated 1088 1088
Noise, Audible 879 879
Component Missing 795 795
Detachment of Device or Device Component 765 765
Malposition of Device 694 694
Migration 683 683
Loss of Osseointegration 680 680
Failure To Adhere Or Bond 526 526
Difficult to Insert 461 461
Patient Device Interaction Problem 415 415
Crack 399 399
Disassembly 383 383
Unintended Movement 330 330
Scratched Material 316 316
Device Operates Differently Than Expected 314 314
Inadequacy of Device Shape and/or Size 312 312
Device Slipped 277 277
Use of Device Problem 274 274
Material Deformation 254 254
Fitting Problem 235 235
Physical Resistance/Sticking 225 225
Patient-Device Incompatibility 203 203
Mechanical Problem 196 196
Packaging Problem 187 187
Osseointegration Problem 185 185
Material Integrity Problem 155 155
Device Contamination with Chemical or Other Material 149 149
Connection Problem 143 143
Material Twisted/Bent 139 139
Material Erosion 127 127
Degraded 122 122
Device-Device Incompatibility 121 121
Corroded 114 114
Positioning Problem 114 114
Tear, Rip or Hole in Device Packaging 109 109
Detachment Of Device Component 103 103
Defective Device 95 95
Material Discolored 88 88
Improper or Incorrect Procedure or Method 86 86
Positioning Failure 83 83
Device Packaging Compromised 81 81
Peeled/Delaminated 80 80
Mechanical Jam 79 79
Device Contaminated During Manufacture or Shipping 78 78
Delivered as Unsterile Product 71 71
Difficult To Position 70 70
Nonstandard Device 69 69
Contamination 69 69
Defective Component 61 61
Material Separation 60 60
No Apparent Adverse Event 60 60
Microbial Contamination of Device 56 56
Device Markings/Labelling Problem 54 54
Material Fragmentation 53 53
Metal Shedding Debris 51 51
Off-Label Use 49 49
Device Damaged Prior to Use 47 47
Manufacturing, Packaging or Shipping Problem 43 43
Illegible Information 40 40
Failure to Align 39 39
Difficult to Remove 35 35
Material Disintegration 35 35
Compatibility Problem 35 35
Incorrect Measurement 32 32
Material Too Rigid or Stiff 31 31
Contamination /Decontamination Problem 31 31
Incomplete or Inadequate Connection 31 31
Bent 29 29
Device Damaged by Another Device 27 27
Unsealed Device Packaging 25 25
Residue After Decontamination 24 24
Biocompatibility 23 23
Product Quality Problem 23 23
Misconnection 21 21
Difficult to Advance 20 20
Collapse 20 20
Expiration Date Error 20 20
Component Incompatible 19 19
Deformation Due to Compressive Stress 18 18
Difficult to Open or Remove Packaging Material 18 18
Incorrect Device Or Component Shipped 18 18
Device Reprocessing Problem 17 17
Device Issue 16 16
Leak/Splash 16 16
Material Rupture 15 15
Misassembled 15 15
Device Or Device Fragments Location Unknown 15 15
Pitted 15 15
Separation Problem 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15889 15891
No Code Available 15476 15476
No Information 8935 8935
Unspecified Infection 8822 8822
Injury 4708 4708
No Known Impact Or Consequence To Patient 4382 4383
No Consequences Or Impact To Patient 4020 4020
Swelling 2115 2115
No Patient Involvement 1968 1968
Limited Mobility Of The Implanted Joint 1679 1679
Not Applicable 1562 1562
Failure of Implant 1552 1552
Bone Fracture(s) 1529 1530
Loss of Range of Motion 1403 1403
Osteolysis 1328 1328
Joint Disorder 1225 1225
Adhesion(s) 1207 1207
Fall 999 1000
Ambulation Difficulties 905 906
Edema 880 880
No Clinical Signs, Symptoms or Conditions 752 752
Joint Dislocation 702 703
Reaction 624 624
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 548 548
Discomfort 537 537
Muscular Rigidity 537 537
Joint Laxity 522 522
Thrombosis 520 520
Inadequate Osseointegration 489 489
Synovitis 466 466
Inflammation 459 459
Hematoma 366 366
Insufficient Information 355 355
Tissue Damage 353 353
Fibrosis 341 341
Scar Tissue 336 336
Swelling/ Edema 316 316
Pulmonary Embolism 290 290
Wound Dehiscence 287 287
Hypersensitivity/Allergic reaction 269 269
Impaired Healing 261 261
Joint Swelling 239 240
Death 236 236
Patient Problem/Medical Problem 203 203
Foreign Body Reaction 196 196
Cyst(s) 193 193
Bacterial Infection 191 191
Implant Pain 184 184
Necrosis 154 154
Hemorrhage/Bleeding 150 150
Cellulitis 144 144
Damage to Ligament(s) 136 136
Post Operative Wound Infection 136 136
Foreign Body In Patient 128 128
Weakness 119 119
Rash 114 114
Numbness 105 105
Blood Loss 98 98
Burning Sensation 93 94
Ossification 89 89
Rupture 82 82
Scarring 81 81
Embolism 78 78
Anemia 78 78
Sepsis 73 73
Urinary Tract Infection 72 72
Fever 69 69
Nerve Damage 66 66
Aspiration/Inhalation 65 65
Device Embedded In Tissue or Plaque 63 63
Osteopenia/ Osteoporosis 61 61
Erythema 60 60
Arthritis 56 56
Fatigue 52 52
Arthralgia 52 52
Alteration In Body Temperature 50 50
Neck Stiffness 50 50
Fluid Discharge 49 49
Tingling 47 47
Local Reaction 47 47
Pneumonia 45 45
Thrombosis/Thrombus 44 44
Abscess 44 44
Myocardial Infarction 43 43
Arrhythmia 37 37
Muscle/Tendon Damage 37 37
Itching Sensation 35 35
Staphylococcus Aureus 34 34
Low Blood Pressure/ Hypotension 31 31
Muscle Weakness 31 32
Skin Discoloration 30 31
Skin Irritation 30 30
Metal Related Pathology 30 30
Unspecified Tissue Injury 30 30
Test Result 29 29
Complaint, Ill-Defined 29 29
Urinary Retention 29 29
Chest Pain 27 27
Peroneal Nerve Palsy 27 27
Hypoesthesia 27 27

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Mar-13-2020
2 Aesculap, Inc. II Mar-03-2016
3 Arthrex, Inc. II Mar-19-2016
4 Biomet, Inc. II Dec-23-2020
5 Biomet, Inc. II May-28-2020
6 Biomet, Inc. II Apr-03-2020
7 ConforMIS, Inc. II Oct-02-2018
8 ConforMIS, Inc. II Feb-13-2018
9 ConforMIS, Inc. II Jan-10-2017
10 ConforMIS, Inc. II Nov-25-2016
11 Conformis, Inc. II Aug-22-2020
12 Conformis, Inc. II Apr-01-2020
13 Conformis, Inc. II Dec-12-2019
14 Conformis, Inc. II Apr-08-2019
15 Conformis, Inc. II Mar-30-2019
16 DePuy Orthopaedics, Inc. II Mar-29-2021
17 DePuy Orthopaedics, Inc. II Feb-09-2021
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 Howmedica Osteonics Corp. II Apr-09-2021
34 Materialise USA LLC II Jun-09-2016
35 Medacta Usa Inc II Dec-20-2017
36 Medtronic Sofamor Danek USA Inc II Mar-21-2017
37 Medtronic Sofamor Danek USA Inc II Aug-23-2016
38 OMNIlife science Inc. II Mar-19-2018
39 Ortho Development Corporation II May-06-2020
40 Signature Orthopedics Pty Limited II Feb-14-2019
41 Smith & Nephew, Inc. II Oct-16-2020
42 Smith & Nephew, Inc. II Aug-08-2020
43 Smith & Nephew, Inc. II Mar-17-2020
44 Smith & Nephew, Inc. II Sep-12-2019
45 Smith & Nephew, Inc. II Mar-22-2019
46 Smith & Nephew, Inc. II Oct-01-2018
47 Smith & Nephew, Inc. II Aug-22-2018
48 Smith & Nephew, Inc. II May-22-2018
49 Smith & Nephew, Inc. II Nov-16-2017
50 Smith & Nephew, Inc. II Jun-12-2017
51 Smith & Nephew, Inc. II Apr-21-2016
52 Smith & Nephew, Inc. II Feb-17-2016
53 Smith & Nephew, Inc. II Jan-04-2016
54 Stanmore Implants Worldwide Ltd. II May-09-2016
55 Stryker Howmedica Osteonics Corp. II Aug-09-2016
56 United Orthopedic Corporation II Mar-19-2018
57 Zimmer Biomet, Inc. II Nov-07-2019
58 Zimmer Biomet, Inc. II Sep-12-2019
59 Zimmer Biomet, Inc. II Apr-04-2019
60 Zimmer Biomet, Inc. II Feb-23-2019
61 Zimmer Biomet, Inc. II Dec-18-2018
62 Zimmer Biomet, Inc. II Nov-21-2018
63 Zimmer Biomet, Inc. II Sep-25-2018
64 Zimmer Biomet, Inc. II Jun-04-2018
65 Zimmer Biomet, Inc. II Jun-01-2018
66 Zimmer Biomet, Inc. II Jun-01-2018
67 Zimmer Biomet, Inc. II May-11-2018
68 Zimmer Biomet, Inc. II Mar-14-2018
69 Zimmer Biomet, Inc. II Feb-21-2018
70 Zimmer Biomet, Inc. II Feb-15-2018
71 Zimmer Biomet, Inc. II May-18-2017
72 Zimmer Biomet, Inc. II Mar-27-2017
73 Zimmer Biomet, Inc. II Feb-16-2017
74 Zimmer Biomet, Inc. II Jan-28-2017
75 Zimmer Biomet, Inc. II Oct-18-2016
76 Zimmer Biomet, Inc. II Oct-03-2016
77 Zimmer Biomet, Inc. II Feb-22-2016
78 Zimmer Manufacturing B.V. II Apr-06-2016
79 Zimmer Manufacturing B.V. II Mar-12-2016
80 Zimmer Manufacturing B.V. II Jan-05-2016
81 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
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