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TPLC - Total Product Life Cycle
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Device prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Product CodeJWH
Regulation Number 888.3560
Device Class 2


Premarket Reviews
ManufacturerDecision
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
B-ONE ORTHO CORP.
  SUBSTANTIALLY EQUIVALENT 2
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING AK MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC
  SUBSTANTIALLY EQUIVALENT 1
BIORAD MEDISYS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 7
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 5
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
CPM MEDICAL CONSULTANTS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 3
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 4
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
L AND K BIOMED CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 3
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 2
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 9
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRCOPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNI LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
OTIS BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION CASTING SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
ROOTLOC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 6
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 10
SMITH&NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STABIL ORTHOPAEDIC SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
STELKAST, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS (AKA HOWMEDICA OSTEONICS CORP.)
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECRES SPA
  SUBSTANTIALLY EQUIVALENT 1
THE PROGRESSIVE ORTHOPAEDIC COMPANY, LLC.
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2017 12262 12262
2018 14032 14032
2019 14989 14989
2020 12594 12594
2021 9439 9439
2022 5707 5707

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20734 20734
Insufficient Information 12472 12472
Fracture 6096 6096
Loss of or Failure to Bond 4822 4822
Appropriate Term/Code Not Available 3579 3579
Break 3502 3502
Unstable 2680 2680
Loosening of Implant Not Related to Bone-Ingrowth 2560 2560
Naturally Worn 2061 2061
Loose or Intermittent Connection 1807 1807
Migration or Expulsion of Device 1523 1523
Device Dislodged or Dislocated 1153 1153
Detachment of Device or Device Component 1035 1035
Noise, Audible 896 896
Migration 883 883
Component Missing 691 691
Malposition of Device 622 622
Loss of Osseointegration 597 597
Patient Device Interaction Problem 560 560
Difficult to Insert 493 493
Crack 453 453
Unintended Movement 335 335
Scratched Material 316 316
Use of Device Problem 310 310
Inadequacy of Device Shape and/or Size 298 298
Material Deformation 267 267
Disassembly 253 253
Osseointegration Problem 239 239
Failure To Adhere Or Bond 234 234
Fitting Problem 233 233
Physical Resistance/Sticking 231 231
Tear, Rip or Hole in Device Packaging 201 201
Packaging Problem 199 199
Mechanical Problem 195 195
Patient-Device Incompatibility 193 193
Device Operates Differently Than Expected 193 193
Device Slipped 178 178
Connection Problem 167 167
Material Twisted/Bent 160 160
Device-Device Incompatibility 149 149
Material Erosion 132 132
Device Contaminated During Manufacture or Shipping 122 122
Positioning Failure 120 120
Corroded 120 120
Failure to Cut 117 117
Device Contamination with Chemical or Other Material 117 117
Defective Device 102 102
Improper or Incorrect Procedure or Method 95 95
Mechanical Jam 93 93
Off-Label Use 88 88
Positioning Problem 80 80
No Apparent Adverse Event 74 74
Delivered as Unsterile Product 74 74
Material Discolored 71 71
Material Integrity Problem 68 68
Device Packaging Compromised 66 66
Contamination 65 65
Difficult To Position 63 63
Degraded 62 62
Material Fragmentation 62 62
Defective Component 62 62
Manufacturing, Packaging or Shipping Problem 58 58
Microbial Contamination of Device 56 56
Difficult to Open or Remove Packaging Material 56 56
Detachment Of Device Component 55 55
Device Damaged Prior to Use 53 53
Material Separation 51 51
Incomplete or Inadequate Connection 51 51
Failure to Align 49 49
Device Markings/Labelling Problem 49 49
Peeled/Delaminated 47 47
Metal Shedding Debris 44 44
Nonstandard Device 41 41
Illegible Information 40 40
Contamination /Decontamination Problem 36 36
Material Disintegration 34 34
Unsealed Device Packaging 32 32
Biocompatibility 32 32
Difficult to Advance 30 30
Incorrect Measurement 30 30
Difficult to Remove 29 29
Material Too Rigid or Stiff 27 27
Device Appears to Trigger Rejection 26 26
Product Quality Problem 25 25
Residue After Decontamination 24 24
Device Damaged by Another Device 24 24
Expiration Date Error 23 23
Bent 22 22
Material Rupture 20 20
Deformation Due to Compressive Stress 20 20
Compatibility Problem 20 20
Misconnection 18 18
Collapse 18 18
Separation Problem 17 17
Failure to Osseointegrate 15 15
Pitted 14 14
Shipping Damage or Problem 14 14
Incomplete or Missing Packaging 13 13
Material Split, Cut or Torn 13 13
Inaccurate Information 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 16880 16882
No Code Available 14219 14219
Unspecified Infection 9638 9638
No Information 7155 7155
Injury 4431 4431
No Consequences Or Impact To Patient 3707 3707
No Clinical Signs, Symptoms or Conditions 3697 3697
No Known Impact Or Consequence To Patient 3479 3480
Failure of Implant 3072 3072
Loss of Range of Motion 2092 2092
Joint Laxity 1912 1912
Swelling 1901 1901
No Patient Involvement 1815 1815
Bone Fracture(s) 1650 1651
Adhesion(s) 1593 1593
Limited Mobility Of The Implanted Joint 1555 1555
Insufficient Information 1548 1548
Not Applicable 1543 1543
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1339 1339
Osteolysis 1242 1242
Fall 1206 1207
Joint Disorder 1187 1187
Swelling/ Edema 1158 1158
Ambulation Difficulties 1140 1141
Edema 862 862
Joint Dislocation 795 796
Muscular Rigidity 764 764
Synovitis 669 669
Discomfort 620 620
Inadequate Osseointegration 616 616
Inflammation 585 585
Scar Tissue 553 553
Reaction 533 533
Thrombosis 506 506
Hematoma 440 440
Wound Dehiscence 369 369
Fibrosis 361 361
Hypersensitivity/Allergic reaction 335 335
Tissue Damage 334 334
Impaired Healing 318 318
Pulmonary Embolism 313 313
Bacterial Infection 289 289
Implant Pain 252 252
Foreign Body Reaction 225 225
Hemorrhage/Bleeding 216 216
Cyst(s) 215 215
Death 206 206
Patient Problem/Medical Problem 196 196
Necrosis 189 189
Damage to Ligament(s) 162 162
Joint Swelling 155 156
Cellulitis 150 150
Unspecified Tissue Injury 148 148
Thrombosis/Thrombus 144 144
Post Operative Wound Infection 141 141
Osteopenia/ Osteoporosis 134 134
Foreign Body In Patient 127 127
Metal Related Pathology 121 121
Numbness 120 120
Rash 120 120
Weakness 114 114
Muscle/Tendon Damage 112 112
Ossification 108 108
Sepsis 103 103
Fluid Discharge 100 100
Blood Loss 97 97
Anemia 93 93
Burning Sensation 90 91
Fatigue 89 89
Erythema 88 88
Rupture 87 87
Limb Fracture 87 87
Nerve Damage 85 85
Fever 84 84
Embolism 77 77
Scarring 77 77
Urinary Tract Infection 74 74
Local Reaction 73 73
Arthritis 66 66
Aspiration/Inhalation 64 64
Unspecified Musculoskeletal problem 64 64
Pneumonia 62 62
Arthralgia 61 61
Abscess 58 58
Device Embedded In Tissue or Plaque 52 52
Joint Contracture 50 50
Alteration In Body Temperature 47 47
Muscle Weakness 47 48
Tingling 46 46
Neck Stiffness 44 44
Myocardial Infarction 43 43
Itching Sensation 41 41
Arrhythmia 41 41
Low Blood Pressure/ Hypotension 37 37
Urinary Retention 34 34
Deformity/ Disfigurement 34 34
Purulent Discharge 30 30
Staphylococcus Aureus 29 29
Renal Failure 29 29
Nausea 29 29

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Mar-13-2020
2 Biomet, Inc. II Dec-23-2020
3 Biomet, Inc. II May-28-2020
4 Biomet, Inc. II Apr-03-2020
5 ConforMIS, Inc. II Oct-02-2018
6 ConforMIS, Inc. II Feb-13-2018
7 ConforMIS, Inc. II Jan-10-2017
8 Conformis, Inc. II Apr-08-2022
9 Conformis, Inc. II Aug-22-2020
10 Conformis, Inc. II Apr-01-2020
11 Conformis, Inc. II Dec-12-2019
12 Conformis, Inc. II Apr-08-2019
13 Conformis, Inc. II Mar-30-2019
14 DePuy Orthopaedics, Inc. II Feb-09-2022
15 DePuy Orthopaedics, Inc. II Oct-07-2021
16 DePuy Orthopaedics, Inc. II Aug-25-2021
17 DePuy Orthopaedics, Inc. II Mar-29-2021
18 DePuy Orthopaedics, Inc. II Feb-09-2021
19 DePuy Orthopaedics, Inc. II Aug-29-2018
20 DePuy Orthopaedics, Inc. II Apr-30-2018
21 Encore Medical, LP II Jun-09-2022
22 Encore Medical, LP II Jul-20-2021
23 Encore Medical, LP II Apr-30-2021
24 Encore Medical, Lp II Aug-31-2018
25 Encore Medical, Lp II Jan-10-2018
26 Encore Medical, Lp II Oct-20-2017
27 Encore Medical, Lp II Jun-30-2017
28 Encore Medical, Lp II Feb-03-2017
29 Exactech, Inc. II Oct-04-2021
30 Exactech, Inc. II Feb-26-2020
31 Exactech, Inc. II Apr-23-2019
32 Exactech, Inc. II Sep-20-2018
33 Exactech, Inc. II Nov-20-2017
34 Exactech, Inc. II Jun-19-2017
35 Howmedica Osteonics Corp. II Jun-03-2022
36 Howmedica Osteonics Corp. II Aug-19-2021
37 Howmedica Osteonics Corp. II Apr-09-2021
38 Medacta Usa Inc II Dec-20-2017
39 Medtronic Sofamor Danek USA Inc II Mar-21-2017
40 OMNIlife science Inc. II Mar-19-2018
41 Ortho Development Corporation II May-06-2020
42 Signature Orthopedics Pty Limited II Feb-14-2019
43 Smith & Nephew Inc II May-16-2022
44 Smith & Nephew, Inc. II Jul-20-2022
45 Smith & Nephew, Inc. II Jun-24-2021
46 Smith & Nephew, Inc. II Oct-16-2020
47 Smith & Nephew, Inc. II Aug-08-2020
48 Smith & Nephew, Inc. II Mar-17-2020
49 Smith & Nephew, Inc. II Sep-12-2019
50 Smith & Nephew, Inc. II Mar-22-2019
51 Smith & Nephew, Inc. II Oct-01-2018
52 Smith & Nephew, Inc. II Aug-22-2018
53 Smith & Nephew, Inc. II May-22-2018
54 Smith & Nephew, Inc. II Nov-16-2017
55 Smith & Nephew, Inc. II Jun-12-2017
56 United Orthopedic Corporation II Mar-19-2018
57 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
58 Zimmer Biomet, Inc. II Nov-07-2019
59 Zimmer Biomet, Inc. II Sep-12-2019
60 Zimmer Biomet, Inc. II Apr-04-2019
61 Zimmer Biomet, Inc. II Feb-23-2019
62 Zimmer Biomet, Inc. II Dec-18-2018
63 Zimmer Biomet, Inc. II Nov-21-2018
64 Zimmer Biomet, Inc. II Sep-25-2018
65 Zimmer Biomet, Inc. II Jun-04-2018
66 Zimmer Biomet, Inc. II Jun-01-2018
67 Zimmer Biomet, Inc. II Jun-01-2018
68 Zimmer Biomet, Inc. II May-11-2018
69 Zimmer Biomet, Inc. II Mar-14-2018
70 Zimmer Biomet, Inc. II Feb-21-2018
71 Zimmer Biomet, Inc. II Feb-15-2018
72 Zimmer Biomet, Inc. II May-18-2017
73 Zimmer Biomet, Inc. II Mar-27-2017
74 Zimmer Biomet, Inc. II Feb-16-2017
75 Zimmer Biomet, Inc. II Jan-28-2017
76 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
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