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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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 4
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 3
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 8
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 4
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
  1.  K173057  Zimmer Knee Joint Replacement Prostheses MR Labeli ...
  2.  K200209  Persona Personalized Knee System
  3.  K210551  Persona Revision Knee System
  4.  K210829  Persona Revision Knee System Femoral Metaphyseal C ...
  5.  K221479  Persona Personalized Knee System
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 5
  1.  K173057  Zimmer Knee Joint Replacement Prostheses MR Labeli ...
  2.  K200209  Persona Personalized Knee System
  3.  K210551  Persona Revision Knee System
  4.  K210829  Persona Revision Knee System Femoral Metaphyseal C ...
  5.  K221479  Persona Personalized Knee System

MDR Year MDR Reports MDR Events
2017 12262 12262
2018 14032 14032
2019 14989 14989
2020 12594 12594
2021 9439 9439
2022 7728 7728

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21631 21631
Insufficient Information 12606 12606
Fracture 6419 6419
Loss of or Failure to Bond 4944 4944
Appropriate Term/Code Not Available 3637 3637
Break 3526 3526
Unstable 2700 2700
Loosening of Implant Not Related to Bone-Ingrowth 2661 2661
Naturally Worn 2192 2192
Loose or Intermittent Connection 1807 1807
Migration or Expulsion of Device 1524 1524
Device Dislodged or Dislocated 1188 1188
Detachment of Device or Device Component 1104 1104
Migration 909 909
Noise, Audible 903 903
Component Missing 692 692
Malposition of Device 623 623
Loss of Osseointegration 601 601
Patient Device Interaction Problem 574 574
Difficult to Insert 509 509
Crack 453 453
Unintended Movement 336 336
Use of Device Problem 322 322
Scratched Material 317 317
Inadequacy of Device Shape and/or Size 304 304
Material Deformation 269 269
Osseointegration Problem 262 262
Disassembly 253 253
Failure To Adhere Or Bond 234 234
Fitting Problem 233 233
Physical Resistance/Sticking 231 231
Tear, Rip or Hole in Device Packaging 202 202
Packaging Problem 200 200
Mechanical Problem 197 197
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 153 153
Material Erosion 137 137
Device Contaminated During Manufacture or Shipping 127 127
Positioning Failure 126 126
Corroded 120 120
Device Contamination with Chemical or Other Material 117 117
Failure to Cut 117 117
Defective Device 102 102
Improper or Incorrect Procedure or Method 102 102
No Apparent Adverse Event 95 95
Mechanical Jam 93 93
Off-Label Use 90 90
Positioning Problem 82 82
Delivered as Unsterile Product 77 77
Material Discolored 71 71
Device Appears to Trigger Rejection 69 69
Material Integrity Problem 69 69
Contamination 66 66
Device Packaging Compromised 66 66
Degraded 66 66
Material Fragmentation 65 65
Defective Component 63 63
Difficult To Position 63 63
Manufacturing, Packaging or Shipping Problem 58 58
Device Damaged Prior to Use 58 58
Difficult to Open or Remove Packaging Material 57 57
Microbial Contamination of Device 56 56
Detachment Of Device Component 55 55
Incomplete or Inadequate Connection 51 51
Material Separation 51 51
Device Markings/Labelling Problem 50 50
Failure to Align 49 49
Peeled/Delaminated 47 47
Metal Shedding Debris 44 44
Nonstandard Device 42 42
Illegible Information 41 41
Contamination /Decontamination Problem 36 36
Biocompatibility 34 34
Material Disintegration 34 34
Unsealed Device Packaging 32 32
Difficult to Advance 30 30
Incorrect Measurement 30 30
Difficult to Remove 29 29
Material Too Rigid or Stiff 27 27
Product Quality Problem 25 25
Device Damaged by Another Device 24 24
Residue After Decontamination 24 24
Expiration Date Error 23 23
Bent 22 22
Compatibility Problem 20 20
Material Rupture 20 20
Deformation Due to Compressive Stress 20 20
Collapse 19 19
Inaccurate Information 19 19
Unexpected Therapeutic Results 18 18
Misconnection 18 18
Separation Problem 17 17
Failure to Osseointegrate 15 15
Pitted 14 14
Material Split, Cut or Torn 14 14
Shipping Damage or Problem 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 17262 17264
No Code Available 14219 14219
Unspecified Infection 9891 9891
No Information 7155 7155
Injury 4431 4431
No Clinical Signs, Symptoms or Conditions 4176 4176
No Consequences Or Impact To Patient 3707 3707
No Known Impact Or Consequence To Patient 3479 3480
Failure of Implant 3378 3378
Loss of Range of Motion 2186 2186
Joint Laxity 2131 2131
Swelling 1901 1901
No Patient Involvement 1815 1815
Insufficient Information 1747 1747
Bone Fracture(s) 1685 1686
Adhesion(s) 1633 1633
Limited Mobility Of The Implanted Joint 1555 1555
Not Applicable 1543 1543
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1369 1369
Osteolysis 1273 1273
Fall 1268 1269
Swelling/ Edema 1249 1249
Joint Disorder 1187 1187
Ambulation Difficulties 1183 1184
Edema 862 862
Muscular Rigidity 813 813
Joint Dislocation 808 809
Synovitis 692 692
Inadequate Osseointegration 649 649
Discomfort 632 632
Inflammation 609 609
Scar Tissue 569 569
Reaction 533 533
Thrombosis 506 506
Hematoma 448 448
Wound Dehiscence 389 389
Fibrosis 367 367
Hypersensitivity/Allergic reaction 338 338
Tissue Damage 334 334
Pulmonary Embolism 327 327
Impaired Healing 320 320
Bacterial Infection 299 299
Implant Pain 277 277
Hemorrhage/Bleeding 232 232
Foreign Body Reaction 231 231
Cyst(s) 220 220
Death 206 206
Patient Problem/Medical Problem 196 196
Necrosis 190 190
Unspecified Tissue Injury 188 188
Damage to Ligament(s) 166 166
Post Operative Wound Infection 161 161
Joint Swelling 155 156
Cellulitis 154 154
Thrombosis/Thrombus 152 152
Osteopenia/ Osteoporosis 134 134
Foreign Body In Patient 128 128
Metal Related Pathology 125 125
Numbness 121 121
Rash 121 121
Fluid Discharge 118 118
Muscle/Tendon Damage 116 116
Weakness 114 114
Ossification 111 111
Sepsis 107 107
Blood Loss 97 97
Limb Fracture 96 96
Anemia 93 93
Fatigue 92 92
Erythema 91 91
Burning Sensation 90 91
Rupture 87 87
Fever 86 86
Nerve Damage 86 86
Urinary Tract Infection 78 78
Scarring 77 77
Embolism 77 77
Unspecified Musculoskeletal problem 74 74
Local Reaction 73 73
Arthralgia 69 69
Arthritis 66 66
Pneumonia 66 66
Aspiration/Inhalation 64 64
Joint Contracture 60 60
Abscess 58 58
Device Embedded In Tissue or Plaque 52 52
Alteration In Body Temperature 47 47
Muscle Weakness 47 48
Tingling 46 46
Neck Stiffness 44 44
Arrhythmia 43 43
Myocardial Infarction 43 43
Itching Sensation 41 41
Deformity/ Disfigurement 38 38
Low Blood Pressure/ Hypotension 37 37
Urinary Retention 34 34
Stroke/CVA 31 31
Erosion 30 30
Purulent Discharge 30 30
Staphylococcus Aureus 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 Corin Ltd II Nov-21-2022
15 DePuy Orthopaedics, Inc. II Feb-09-2022
16 DePuy Orthopaedics, Inc. II Oct-07-2021
17 DePuy Orthopaedics, Inc. II Aug-25-2021
18 DePuy Orthopaedics, Inc. II Mar-29-2021
19 DePuy Orthopaedics, Inc. II Feb-09-2021
20 DePuy Orthopaedics, Inc. II Aug-29-2018
21 DePuy Orthopaedics, Inc. II Apr-30-2018
22 Encore Medical, LP II Jun-09-2022
23 Encore Medical, LP II Jul-20-2021
24 Encore Medical, LP II Apr-30-2021
25 Encore Medical, Lp II Aug-31-2018
26 Encore Medical, Lp II Jan-10-2018
27 Encore Medical, Lp II Oct-20-2017
28 Encore Medical, Lp II Jun-30-2017
29 Encore Medical, Lp II Feb-03-2017
30 Exactech, Inc. II Oct-04-2021
31 Exactech, Inc. II Feb-26-2020
32 Exactech, Inc. II Apr-23-2019
33 Exactech, Inc. II Sep-20-2018
34 Exactech, Inc. II Nov-20-2017
35 Exactech, Inc. II Jun-19-2017
36 Howmedica Osteonics Corp. II Jun-03-2022
37 Howmedica Osteonics Corp. II Aug-19-2021
38 Howmedica Osteonics Corp. II Apr-09-2021
39 Medacta Usa Inc II Dec-20-2017
40 Medtronic Sofamor Danek USA Inc II Mar-21-2017
41 OMNIlife science Inc. II Mar-19-2018
42 Ortho Development Corporation II May-06-2020
43 Signature Orthopedics Pty Limited II Feb-14-2019
44 Smith & Nephew Inc II May-16-2022
45 Smith & Nephew, Inc. II Jul-20-2022
46 Smith & Nephew, Inc. II Jun-24-2021
47 Smith & Nephew, Inc. II Oct-16-2020
48 Smith & Nephew, Inc. II Aug-08-2020
49 Smith & Nephew, Inc. II Mar-17-2020
50 Smith & Nephew, Inc. II Sep-12-2019
51 Smith & Nephew, Inc. II Mar-22-2019
52 Smith & Nephew, Inc. II Oct-01-2018
53 Smith & Nephew, Inc. II Aug-22-2018
54 Smith & Nephew, Inc. II May-22-2018
55 Smith & Nephew, Inc. II Nov-16-2017
56 Smith & Nephew, Inc. II Jun-12-2017
57 United Orthopedic Corporation II Mar-19-2018
58 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
59 Zimmer Biomet, Inc. II Nov-07-2019
60 Zimmer Biomet, Inc. II Sep-12-2019
61 Zimmer Biomet, Inc. II Apr-04-2019
62 Zimmer Biomet, Inc. II Feb-23-2019
63 Zimmer Biomet, Inc. II Dec-18-2018
64 Zimmer Biomet, Inc. II Nov-21-2018
65 Zimmer Biomet, Inc. II Sep-25-2018
66 Zimmer Biomet, Inc. II Jun-04-2018
67 Zimmer Biomet, Inc. II Jun-01-2018
68 Zimmer Biomet, Inc. II Jun-01-2018
69 Zimmer Biomet, Inc. II May-11-2018
70 Zimmer Biomet, Inc. II Mar-14-2018
71 Zimmer Biomet, Inc. II Feb-21-2018
72 Zimmer Biomet, Inc. II Feb-15-2018
73 Zimmer Biomet, Inc. II May-18-2017
74 Zimmer Biomet, Inc. II Mar-27-2017
75 Zimmer Biomet, Inc. II Feb-16-2017
76 Zimmer Biomet, Inc. II Jan-28-2017
77 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
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