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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
AESCULAP IMPLANT SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP IMPLANT SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
AESCULAP IMPLANTS SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 2
ANOVA IMPLANT SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 4
B-ONE ORTHO CORP.
  SUBSTANTIALLY EQUIVALENT 2
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 4
BEIJING AK MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING CHUNLIZHENGDA MEDICAL INSTRUMENTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 4
BIOMET, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 5
BIORAD MEDISYS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
CARDO MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDO MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 9
CONFORMIS, INC
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 28
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 2
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 7
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORIN U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
CPM MEDICAL CONSULTANTS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 3
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
ENCORE MEDICAL, L.P DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 11
ENCORE MEDICAL, L.P. (DBA ENOVIS)
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P. DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 1
ENDOTEC, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 3
EXACTECH SARASOTA
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 10
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
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 4
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 3
MAKO SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 8
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 3
MATORTHO
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 10
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 9
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 4
MERIL HEALTHCARE PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 3
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 4
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRCOPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEW ERA ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NOVOSOURCE INC
  SUBSTANTIALLY EQUIVALENT 2
OMNI LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 5
OMNILIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 3
OMNILIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 2
OMNLIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 4
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
ORTHOSOFT INC. (D/B/A ZIMMER CAS)
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSOFT, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
OTIS BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PERMEDICA
  SUBSTANTIALLY EQUIVALENT 1
PIPELINE ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 6
PRECISION CASTING SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
RESPONSIVE ORTHOPEDICS LLC
  SUBSTANTIALLY EQUIVALENT 1
ROOTLOC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIGNAL MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 9
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 30
SMITH&NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STABIL ORTHOPAEDIC SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
STELKAST COMPANY
  SUBSTANTIALLY EQUIVALENT 1
STELKAST, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS (AKA HOWMEDICA OSTEONICS CORP.)
  SUBSTANTIALLY EQUIVALENT 1
SURGTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECRES SPA
  SUBSTANTIALLY EQUIVALENT 1
TGM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
THE PROGRESSIVE ORTHOPAEDIC COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 2
THE PROGRESSIVE ORTHOPAEDIC COMPANY, LLC.
  SUBSTANTIALLY EQUIVALENT 1
TJC LIFE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TORNIER
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 12
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
U&I CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 11
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 6
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 10

MDR Year MDR Reports MDR Events
2014 6710 6710
2015 6877 6877
2016 7583 7583
2017 12262 12262
2018 14034 14034
2019 14986 14986
2020 12590 12590
2021 9406 9406
2022 8360 8360
2023 8983 8989
2024 4166 4360

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 28595 28727
Insufficient Information 21191 21191
Fracture 9199 9199
Loss of or Failure to Bond 7167 7167
Naturally Worn 5119 5119
Break 5008 5008
Appropriate Term/Code Not Available 4686 4686
Unstable 4006 4006
Loosening of Implant Not Related to Bone-Ingrowth 3581 3617
Loose or Intermittent Connection 2651 2651
Migration or Expulsion of Device 2011 2011
Device Dislodged or Dislocated 1826 1826
Detachment of Device or Device Component 1426 1426
Noise, Audible 1268 1268
Migration 1095 1095
Failure To Adhere Or Bond 1023 1023
Malposition of Device 959 959
Component Missing 932 932
Difficult to Insert 916 916
Loss of Osseointegration 915 915
Device Slipped 859 859
Device Operates Differently Than Expected 685 685
Patient Device Interaction Problem 635 635
Crack 620 620
Disassembly 543 543
Inadequacy of Device Shape and/or Size 517 517
Use of Device Problem 398 398
Unintended Movement 376 376
Scratched Material 351 351
Osseointegration Problem 349 349
Device Appears to Trigger Rejection 335 335
Fitting Problem 329 329
Material Integrity Problem 322 322
Material Deformation 309 309
Packaging Problem 301 301
Tear, Rip or Hole in Device Packaging 297 297
Mechanical Problem 285 285
Patient-Device Incompatibility 271 271
Physical Resistance/Sticking 231 231
Material Erosion 215 215
Detachment Of Device Component 203 203
Positioning Failure 195 195
Improper or Incorrect Procedure or Method 193 193
Degraded 187 219
Connection Problem 187 187
Device Contaminated During Manufacture or Shipping 183 183
Device Contamination with Chemical or Other Material 181 181
Positioning Problem 174 174
Device-Device Incompatibility 169 169
Material Twisted/Bent 165 165
No Apparent Adverse Event 164 164
Corroded 159 159
Device Packaging Compromised 126 126
Off-Label Use 125 125
Defective Device 120 120
Delivered as Unsterile Product 117 117
Failure to Cut 115 115
Mechanical Jam 113 113
Manufacturing, Packaging or Shipping Problem 111 111
Peeled/Delaminated 109 109
Material Discolored 105 105
Nonstandard Device 104 104
Contamination 100 100
Failure to Align 97 97
Metal Shedding Debris 95 95
Material Fragmentation 91 91
Material Separation 87 87
Difficult to Open or Remove Packaging Material 82 82
Device Damaged Prior to Use 81 81
Defective Component 79 79
Device Markings/Labelling Problem 75 75
Difficult To Position 74 74
Material Too Rigid or Stiff 66 66
Difficult to Remove 60 60
Microbial Contamination of Device 57 57
Biocompatibility 53 53
Unsealed Device Packaging 52 52
Incomplete or Inadequate Connection 51 51
Compatibility Problem 46 46
Material Disintegration 46 46
Contamination /Decontamination Problem 44 44
Illegible Information 42 42
Sticking 42 42
Collapse 38 38
Expiration Date Error 37 37
Bent 35 35
Incorrect Measurement 33 33
Failure to Osseointegrate 32 32
Material Rupture 32 32
Difficult to Advance 32 32
Device Damaged by Another Device 31 31
Device Disinfection Or Sterilization Issue 30 30
Mechanics Altered 29 29
Component Falling 28 28
Component Incompatible 28 28
Product Quality Problem 26 26
Incomplete or Missing Packaging 26 26
Residue After Decontamination 26 26
Pitted 25 25
Wrong Label 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 25950 26001
No Code Available 18187 18187
Unspecified Infection 14886 14886
No Information 11516 11516
No Clinical Signs, Symptoms or Conditions 6543 6543
Failure of Implant 6096 6096
No Known Impact Or Consequence To Patient 5245 5246
Injury 4907 4907
No Consequences Or Impact To Patient 4263 4263
Joint Laxity 3687 3687
Insufficient Information 3540 3690
Loss of Range of Motion 3070 3112
Swelling 2441 2441
Osteolysis 2423 2423
Bone Fracture(s) 2279 2280
No Patient Involvement 1995 1995
Adhesion(s) 1903 1903
Swelling/ Edema 1885 1891
Fall 1860 1861
Limited Mobility Of The Implanted Joint 1834 1834
Ambulation Difficulties 1770 1773
Not Applicable 1564 1564
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1529 1529
Joint Disorder 1238 1238
Muscular Rigidity 1067 1067
Joint Dislocation 1057 1058
Synovitis 995 995
Discomfort 901 901
Edema 886 886
Inadequate Osseointegration 836 836
Scar Tissue 805 805
Inflammation 786 786
Reaction 695 695
Implant Pain 645 645
Hematoma 544 544
Thrombosis 528 528
Hypersensitivity/Allergic reaction 511 511
Fibrosis 478 478
Wound Dehiscence 477 477
Unspecified Tissue Injury 433 433
Bacterial Infection 419 419
Tissue Damage 406 406
Foreign Body Reaction 392 392
Impaired Healing 375 375
Pulmonary Embolism 360 360
Joint Swelling 321 322
Hemorrhage/Bleeding 305 305
Cyst(s) 282 282
Death 248 248
Necrosis 242 242
Damage to Ligament(s) 235 235
Thrombosis/Thrombus 232 232
Post Operative Wound Infection 213 213
Patient Problem/Medical Problem 207 207
Metal Related Pathology 190 190
Fluid Discharge 181 181
Muscle/Tendon Damage 178 178
Foreign Body In Patient 172 172
Cellulitis 169 169
Numbness 165 165
Limb Fracture 164 164
Osteopenia/ Osteoporosis 161 161
Sepsis 158 158
Arthralgia 155 155
Rash 152 152
Ossification 137 137
Unspecified Musculoskeletal problem 135 135
Rupture 126 126
Erythema 124 124
Nerve Damage 122 122
Weakness 122 122
Fatigue 119 119
Burning Sensation 115 116
Anemia 111 111
Arthritis 109 109
Fever 107 107
Joint Contracture 103 103
Complaint, Ill-Defined 102 102
Blood Loss 100 100
Device Embedded In Tissue or Plaque 95 95
Scarring 95 95
Urinary Tract Infection 81 81
Pneumonia 80 80
Embolism 80 80
Local Reaction 78 78
Abscess 71 71
Toxicity 71 71
Muscle Weakness 69 70
Aspiration/Inhalation 67 67
Deformity/ Disfigurement 62 62
Erosion 59 59
Subluxation 57 57
Neck Stiffness 54 54
Myocardial Infarction 53 53
Itching Sensation 53 53
Arrhythmia 52 52
Alteration In Body Temperature 52 52
Staphylococcus Aureus 50 50
Tingling 47 47
Laceration(s) 46 46

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 Aesculap, Inc. II Dec-13-2013
5 Arthrex, Inc. II Mar-19-2016
6 Biomet, Inc. II Jan-30-2023
7 Biomet, Inc. II Dec-23-2020
8 Biomet, Inc. II May-28-2020
9 Biomet, Inc. II Apr-03-2020
10 Biomet, Inc. III Jun-11-2015
11 Biomet, Inc. II Aug-15-2014
12 Biomet, Inc. II Dec-13-2013
13 Biomet, Inc. II Mar-02-2012
14 Biomet, Inc. II Jan-11-2012
15 Biomet, Inc. II Aug-04-2011
16 Biomet, Inc. II Apr-28-2011
17 Biomet, Inc. II Aug-10-2010
18 CORENTEC CO., LTD II May-31-2024
19 ConforMIS, Inc. II Oct-02-2018
20 ConforMIS, Inc. II Feb-13-2018
21 ConforMIS, Inc. II Jan-10-2017
22 ConforMIS, Inc. II Nov-25-2016
23 ConforMIS, Inc. II Oct-21-2015
24 ConforMIS, Inc. II Dec-11-2014
25 Conformis Inc II Aug-17-2012
26 Conformis, Inc. II Apr-17-2024
27 Conformis, Inc. II Apr-08-2022
28 Conformis, Inc. II Aug-22-2020
29 Conformis, Inc. II Apr-01-2020
30 Conformis, Inc. II Dec-12-2019
31 Conformis, Inc. II Apr-08-2019
32 Conformis, Inc. II Mar-30-2019
33 Corin Ltd II Nov-02-2023
34 Corin Ltd II Nov-21-2022
35 DePuy Orthopaedics, Inc. II Feb-09-2022
36 DePuy Orthopaedics, Inc. II Oct-07-2021
37 DePuy Orthopaedics, Inc. II Aug-25-2021
38 DePuy Orthopaedics, Inc. II Mar-29-2021
39 DePuy Orthopaedics, Inc. II Feb-09-2021
40 DePuy Orthopaedics, Inc. II Aug-29-2018
41 DePuy Orthopaedics, Inc. II Apr-30-2018
42 DePuy Orthopaedics, Inc. II Mar-13-2014
43 DePuy Orthopaedics, Inc. II Feb-24-2014
44 DePuy Orthopaedics, Inc. II Nov-27-2013
45 DePuy Orthopaedics, Inc. I Jul-31-2013
46 DePuy Orthopaedics, Inc. II Aug-30-2011
47 Depuy Orthopaedics, Inc. II Aug-21-2009
48 Encore Medical, LP II Oct-12-2023
49 Encore Medical, LP II Sep-19-2023
50 Encore Medical, LP II Feb-27-2023
51 Encore Medical, LP II Jun-09-2022
52 Encore Medical, LP II Jul-20-2021
53 Encore Medical, LP II Apr-30-2021
54 Encore Medical, Lp II Aug-31-2018
55 Encore Medical, Lp II Jan-10-2018
56 Encore Medical, Lp II Oct-20-2017
57 Encore Medical, Lp II Jun-30-2017
58 Encore Medical, Lp II Feb-03-2017
59 Encore Medical, Lp II Dec-14-2016
60 Encore Medical, Lp II Dec-06-2016
61 Encore Medical, Lp II Oct-28-2016
62 Encore Medical, Lp II Dec-02-2011
63 Encore Medical, Lp II Aug-22-2010
64 Encore Medical, Lp II Apr-26-2010
65 Encore Medical, Lp II Apr-07-2010
66 Encore Medical, Lp II Feb-24-2010
67 Encore Medical, Lp II Jan-13-2010
68 Endotec, Inc. II May-20-2010
69 Exactech, Inc. II Jan-18-2024
70 Exactech, Inc. II Oct-04-2021
71 Exactech, Inc. II Feb-26-2020
72 Exactech, Inc. II Apr-23-2019
73 Exactech, Inc. II Sep-20-2018
74 Exactech, Inc. II Nov-20-2017
75 Exactech, Inc. II Jun-19-2017
76 Exactech, Inc. II Jan-05-2015
77 Exactech, Inc. II Mar-15-2013
78 Exactech, Inc. II Sep-04-2012
79 Exactech, Inc. II Aug-21-2012
80 Exactech, Inc. II Jul-24-2012
81 Howmedica Osteonics Corp. II Jan-31-2024
82 Howmedica Osteonics Corp. II Jun-03-2022
83 Howmedica Osteonics Corp. II Aug-19-2021
84 Howmedica Osteonics Corp. II Apr-09-2021
85 Limacorporate S.p.A II Dec-09-2023
86 Linkbio Corp. II Jun-01-2023
87 Materialise N.V. II Jul-20-2023
88 Materialise N.V. II Mar-17-2015
89 Materialise USA LLC II Jun-09-2016
90 Materialise USA LLC II Nov-21-2014
91 Materialise USA LLC II May-14-2012
92 Medacta Usa Inc II Dec-20-2017
93 Medacta Usa Inc II Jun-26-2015
94 Medtronic Sofamor Danek USA Inc II Mar-21-2017
95 Medtronic Sofamor Danek USA Inc II Aug-23-2016
96 Microport Orthopedics INC. II Mar-06-2015
97 OMNIlife science Inc. II Mar-19-2018
98 Omni Life Science II Sep-13-2012
99 Ortho Development Corporation II May-06-2020
100 Ortho Development Corporation II Jun-26-2015
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