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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 1
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 1
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 7

MDR Year MDR Reports MDR Events
2016 7576 7576
2017 12256 12256
2018 14028 14028
2019 15001 15001
2020 12610 12610

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 14845 14845
Adverse Event Without Identified Device or Use Problem 14452 14452
Fracture 5051 5051
Loss of or Failure to Bond 4544 4544
Break 3380 3380
Appropriate Term/Code Not Available 2714 2714
Unstable 2499 2499
Naturally Worn 1835 1835
Loose or Intermittent Connection 1802 1802
Migration or Expulsion of Device 1749 1749
Loosening of Implant Not Related to Bone-Ingrowth 1568 1568
Device Dislodged or Dislocated 1066 1066
Noise, Audible 858 858
Component Missing 790 790
Detachment of Device or Device Component 712 712
Malposition of Device 684 684
Loss of Osseointegration 663 663
Migration 657 657
Failure To Adhere Or Bond 526 526
Difficult to Insert 434 434
Disassembly 383 383
Crack 378 378
Patient Device Interaction Problem 333 333
Unintended Movement 318 318
Scratched Material 316 316
Device Operates Differently Than Expected 314 314
Inadequacy of Device Shape and/or Size 292 292
Device Slipped 277 277
Use of Device Problem 260 260
Material Deformation 249 249
Fitting Problem 228 228
Physical Resistance/Sticking 221 221
Patient-Device Incompatibility 186 186
Mechanical Problem 185 185
Packaging Problem 181 181
Osseointegration Problem 169 169
Material Integrity Problem 150 150
Device Contamination with Chemical or Other Material 149 149
Material Twisted/Bent 136 136
Degraded 122 122
Device-Device Incompatibility 121 121
Material Erosion 117 117
Corroded 113 113
Positioning Problem 107 107
Detachment Of Device Component 102 102
Tear, Rip or Hole in Device Packaging 102 102
Connection Problem 101 101
Defective Device 95 95
Material Discolored 88 88
Improper or Incorrect Procedure or Method 84 84
Device Packaging Compromised 81 81
Peeled/Delaminated 79 79
Positioning Failure 78 78
Device Contaminated During Manufacture or Shipping 72 72
Difficult To Position 70 70
Contamination 68 68
Delivered as Unsterile Product 67 67
Nonstandard Device 64 64
Mechanical Jam 64 64
Screw 61 61
Defective Component 60 60
No Apparent Adverse Event 60 60
Material Separation 59 59
Microbial Contamination of Device 56 56
Device Markings/Labelling Problem 53 53
Metal Shedding Debris 51 51
Material Fragmentation 48 48
Off-Label Use 47 47
Device Damaged Prior to Use 46 46
Manufacturing, Packaging or Shipping Problem 40 40
Illegible Information 39 39
Difficult to Remove 35 35
Failure to Align 35 35
Material Disintegration 35 35
Compatibility Problem 34 34
Incorrect Measurement 30 30
Material Too Rigid or Stiff 30 30
Bent 29 29
Contamination /Decontamination Problem 29 29
Device Damaged by Another Device 27 27
Unsealed Device Packaging 25 25
Residue After Decontamination 24 24
Product Quality Problem 23 23
Biocompatibility 22 22
Misconnection 21 21
Incomplete or Inadequate Connection 20 20
Collapse 19 19
Component Incompatible 19 19
Expiration Date Error 19 19
Difficult to Open or Remove Packaging Material 18 18
Incorrect Device Or Component Shipped 18 18
Handpiece 17 17
Deformation Due to Compressive Stress 17 17
Device Issue 16 16
Leak/Splash 16 16
Pin 15 15
Material Rupture 15 15
Difficult to Advance 15 15
Device Or Device Fragments Location Unknown 15 15
Pitted 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 15463 15463
Pain 15238 15238
No Information 8909 8909
Unspecified Infection 8650 8650
Injury 4707 4707
No Known Impact Or Consequence To Patient 4343 4344
No Consequences Or Impact To Patient 3983 3983
Swelling 2098 2098
No Patient Involvement 1879 1879
Limited Mobility Of The Implanted Joint 1657 1657
Not Applicable 1562 1562
Bone Fracture(s) 1489 1489
Failure of Implant 1363 1363
Loss of Range of Motion 1282 1282
Osteolysis 1282 1282
Joint Disorder 1225 1225
Adhesion(s) 1111 1111
Fall 935 935
Edema 879 879
Ambulation Difficulties 751 751
Joint Dislocation 669 670
Reaction 615 615
Thrombosis 519 519
Discomfort 495 495
Muscular Rigidity 458 458
Inadequate Osseointegration 450 450
Inflammation 434 434
Synovitis 401 401
Hematoma 359 359
Tissue Damage 349 349
Fibrosis 332 332
Scar Tissue 310 310
Pulmonary Embolism 281 281
Wound Dehiscence 268 268
Hypersensitivity/Allergic reaction 262 262
Impaired Healing 256 256
Joint Swelling 238 238
Death 235 235
No Clinical Signs, Symptoms or Conditions 234 234
Joint Laxity 203 203
Patient Problem/Medical Problem 202 202
Foreign Body Reaction 196 196
Bacterial Infection 182 182
Cyst(s) 179 179
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 166 166
Insufficient Information 150 150
Necrosis 145 145
Cellulitis 143 143
Hemorrhage/Bleeding 137 137
Damage to Ligament(s) 132 132
Swelling/ Edema 126 126
Weakness 119 119
Post Operative Wound Infection 117 117
Foreign Body In Patient 117 117
Rash 112 112
Numbness 98 98
Blood Loss 98 98
Burning Sensation 87 87
Ossification 82 82
Scarring 81 81
Rupture 81 81
Embolism 78 78
Sepsis 74 74
Urinary Tract Infection 72 72
Anemia 71 71
Implant Pain 66 66
Aspiration/Inhalation 65 65
Fever 65 65
Device Embedded In Tissue or Plaque 61 61
Nerve Damage 61 61
Erythema 60 60
Arthritis 57 57
Osteopenia/ Osteoporosis 57 57
Neck Stiffness 50 50
Alteration In Body Temperature 50 50
Arthralgia 49 49
Fluid Discharge 49 49
Fatigue 47 47
Tingling 47 47
Pneumonia 45 45
Myocardial Infarction 43 43
Abscess 39 39
Arrhythmia 37 37
Local Reaction 35 35
Staphylococcus Aureus 34 34
Itching Sensation 33 33
Skin Irritation 30 30
Muscle Weakness 30 30
Low Blood Pressure/ Hypotension 29 29
Skin Discoloration 29 29
Urinary Retention 29 29
Complaint, Ill-Defined 29 29
Test Result 29 29
Peroneal Nerve Palsy 27 27
Chest Pain 27 27
Hypoesthesia 27 27
Purulent Discharge 24 24
Nausea 24 24
Fungal Infection 22 22
Sleep Dysfunction 21 21

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 Aug-29-2018
17 DePuy Orthopaedics, Inc. II Apr-30-2018
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 Feb-26-2020
27 Exactech, Inc. II Apr-23-2019
28 Exactech, Inc. II Sep-20-2018
29 Exactech, Inc. II Nov-20-2017
30 Exactech, Inc. II Jun-19-2017
31 Materialise USA LLC II Jun-09-2016
32 Medacta Usa Inc II Dec-20-2017
33 Medtronic Sofamor Danek USA Inc II Mar-21-2017
34 Medtronic Sofamor Danek USA Inc II Aug-23-2016
35 OMNIlife science Inc. II Mar-19-2018
36 Ortho Development Corporation II May-06-2020
37 Signature Orthopedics Pty Limited II Feb-14-2019
38 Smith & Nephew, Inc. II Oct-16-2020
39 Smith & Nephew, Inc. II Aug-08-2020
40 Smith & Nephew, Inc. II Mar-17-2020
41 Smith & Nephew, Inc. II Sep-12-2019
42 Smith & Nephew, Inc. II Mar-22-2019
43 Smith & Nephew, Inc. II Oct-01-2018
44 Smith & Nephew, Inc. II Aug-22-2018
45 Smith & Nephew, Inc. II May-22-2018
46 Smith & Nephew, Inc. II Nov-16-2017
47 Smith & Nephew, Inc. II Jun-12-2017
48 Smith & Nephew, Inc. II Apr-21-2016
49 Smith & Nephew, Inc. II Feb-17-2016
50 Smith & Nephew, Inc. II Jan-04-2016
51 Stanmore Implants Worldwide Ltd. II May-09-2016
52 Stryker Howmedica Osteonics Corp. II Aug-09-2016
53 United Orthopedic Corporation II Mar-19-2018
54 Zimmer Biomet, Inc. II Nov-07-2019
55 Zimmer Biomet, Inc. II Sep-12-2019
56 Zimmer Biomet, Inc. II Apr-04-2019
57 Zimmer Biomet, Inc. II Feb-23-2019
58 Zimmer Biomet, Inc. II Dec-18-2018
59 Zimmer Biomet, Inc. II Nov-21-2018
60 Zimmer Biomet, Inc. II Sep-25-2018
61 Zimmer Biomet, Inc. II Jun-04-2018
62 Zimmer Biomet, Inc. II Jun-01-2018
63 Zimmer Biomet, Inc. II Jun-01-2018
64 Zimmer Biomet, Inc. II May-11-2018
65 Zimmer Biomet, Inc. II Mar-14-2018
66 Zimmer Biomet, Inc. II Feb-21-2018
67 Zimmer Biomet, Inc. II Feb-15-2018
68 Zimmer Biomet, Inc. II May-18-2017
69 Zimmer Biomet, Inc. II Mar-27-2017
70 Zimmer Biomet, Inc. II Feb-16-2017
71 Zimmer Biomet, Inc. II Jan-28-2017
72 Zimmer Biomet, Inc. II Oct-18-2016
73 Zimmer Biomet, Inc. II Oct-03-2016
74 Zimmer Biomet, Inc. II Feb-22-2016
75 Zimmer Manufacturing B.V. II Apr-06-2016
76 Zimmer Manufacturing B.V. II Mar-12-2016
77 Zimmer Manufacturing B.V. II Jan-05-2016
78 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
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