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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
B-ONE ORTHO CORP.
  SUBSTANTIALLY EQUIVALENT 2
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING AK MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC
  SUBSTANTIALLY EQUIVALENT 1
BIORAD MEDISYS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 4
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 10
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
CORENTEC CO., LTD.
  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 2
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 5
EXACTECH INC
  SUBSTANTIALLY EQUIVALENT 3
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 2
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 2
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 9
MERIL HEALTHCARE PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 8
SMITH&NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STABIL ORTHOPAEDIC SOLUTIONS, LLC
  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
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
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2016 7585 7585
2017 12262 12262
2018 14031 14031
2019 14989 14989
2020 12594 12594
2021 7259 7259

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 17549 17549
Insufficient Information 14955 14955
Fracture 5707 5707
Loss of or Failure to Bond 5009 5009
Break 3835 3835
Appropriate Term/Code Not Available 3271 3271
Unstable 2772 2772
Loosening of Implant Not Related to Bone-Ingrowth 2060 2060
Naturally Worn 2059 2059
Loose or Intermittent Connection 1929 1929
Migration or Expulsion of Device 1756 1756
Device Dislodged or Dislocated 1188 1188
Noise, Audible 916 916
Detachment of Device or Device Component 862 862
Component Missing 799 799
Migration 757 757
Malposition of Device 708 708
Loss of Osseointegration 687 687
Failure To Adhere Or Bond 526 526
Difficult to Insert 511 511
Patient Device Interaction Problem 468 468
Crack 467 467
Disassembly 383 383
Inadequacy of Device Shape and/or Size 341 341
Unintended Movement 332 332
Scratched Material 326 326
Device Operates Differently Than Expected 314 314
Use of Device Problem 295 295
Device Slipped 277 277
Material Deformation 265 265
Fitting Problem 256 256
Physical Resistance/Sticking 231 231
Osseointegration Problem 219 219
Patient-Device Incompatibility 216 216
Mechanical Problem 202 202
Packaging Problem 194 194
Connection Problem 170 170
Material Integrity Problem 155 155
Material Twisted/Bent 154 154
Device Contamination with Chemical or Other Material 150 150
Material Erosion 143 143
Corroded 127 127
Device-Device Incompatibility 125 125
Degraded 121 121
Tear, Rip or Hole in Device Packaging 118 118
Positioning Problem 115 115
Detachment Of Device Component 103 103
Defective Device 100 100
Device Contaminated During Manufacture or Shipping 98 98
Improper or Incorrect Procedure or Method 94 94
Positioning Failure 93 93
Mechanical Jam 89 89
Material Discolored 88 88
Device Packaging Compromised 81 81
Peeled/Delaminated 80 80
Delivered as Unsterile Product 74 74
Contamination 71 71
Nonstandard Device 70 70
Difficult To Position 70 70
Off-Label Use 69 69
No Apparent Adverse Event 67 67
Material Fragmentation 62 62
Defective Component 62 62
Material Separation 61 61
Failure to Cut 60 60
Device Markings/Labelling Problem 57 57
Microbial Contamination of Device 56 56
Metal Shedding Debris 51 51
Incomplete or Inadequate Connection 50 50
Manufacturing, Packaging or Shipping Problem 49 49
Device Damaged Prior to Use 48 48
Failure to Align 48 48
Illegible Information 40 40
Difficult to Remove 37 37
Material Disintegration 36 36
Compatibility Problem 35 35
Contamination /Decontamination Problem 34 34
Unsealed Device Packaging 33 33
Difficult to Open or Remove Packaging Material 33 33
Incorrect Measurement 32 32
Material Too Rigid or Stiff 32 32
Bent 29 29
Device Damaged by Another Device 28 28
Difficult to Advance 26 26
Residue After Decontamination 24 24
Product Quality Problem 24 24
Biocompatibility 23 23
Collapse 22 22
Expiration Date Error 21 21
Misconnection 21 21
Component Incompatible 19 19
Deformation Due to Compressive Stress 18 18
Incorrect Device Or Component Shipped 18 18
Material Rupture 17 17
Device Reprocessing Problem 17 17
Pitted 17 17
Device Issue 16 16
Separation Problem 16 16
Misassembled 16 16
Leak/Splash 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 17078 17080
No Code Available 15457 15457
Unspecified Infection 9168 9168
No Information 8934 8934
Injury 4698 4698
No Known Impact Or Consequence To Patient 4381 4382
No Consequences Or Impact To Patient 4019 4019
Swelling 2115 2115
Failure of Implant 2045 2045
No Patient Involvement 1968 1968
No Clinical Signs, Symptoms or Conditions 1848 1848
Loss of Range of Motion 1745 1745
Limited Mobility Of The Implanted Joint 1679 1679
Bone Fracture(s) 1600 1601
Not Applicable 1562 1562
Adhesion(s) 1418 1418
Osteolysis 1386 1386
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1250 1250
Joint Disorder 1225 1225
Fall 1102 1103
Joint Laxity 1097 1097
Ambulation Difficulties 1045 1046
Edema 871 871
Insufficient Information 855 855
Joint Dislocation 771 772
Swelling/ Edema 652 652
Muscular Rigidity 637 637
Reaction 622 622
Discomfort 581 581
Inadequate Osseointegration 564 564
Synovitis 559 559
Thrombosis 520 520
Inflammation 504 504
Scar Tissue 431 431
Hematoma 410 410
Fibrosis 360 360
Tissue Damage 353 353
Wound Dehiscence 322 322
Hypersensitivity/Allergic reaction 303 303
Pulmonary Embolism 299 299
Impaired Healing 281 281
Joint Swelling 239 240
Death 236 236
Implant Pain 230 230
Foreign Body Reaction 223 223
Bacterial Infection 223 223
Cyst(s) 220 220
Patient Problem/Medical Problem 203 203
Hemorrhage/Bleeding 169 169
Necrosis 165 165
Damage to Ligament(s) 154 154
Post Operative Wound Infection 151 151
Cellulitis 148 148
Foreign Body In Patient 136 136
Rash 123 123
Weakness 119 119
Numbness 112 112
Thrombosis/Thrombus 106 106
Ossification 103 103
Blood Loss 98 98
Burning Sensation 97 98
Rupture 86 86
Sepsis 86 86
Anemia 85 85
Scarring 81 81
Embolism 78 78
Osteopenia/ Osteoporosis 77 77
Fever 75 75
Urinary Tract Infection 72 72
Nerve Damage 69 69
Erythema 68 68
Metal Related Pathology 68 68
Muscle/Tendon Damage 68 68
Aspiration/Inhalation 65 65
Fatigue 64 64
Device Embedded In Tissue or Plaque 63 63
Arthralgia 61 61
Local Reaction 61 61
Fluid Discharge 60 60
Arthritis 59 59
Limb Fracture 53 53
Alteration In Body Temperature 50 50
Neck Stiffness 50 50
Pneumonia 48 48
Tingling 47 47
Abscess 45 45
Myocardial Infarction 43 43
Itching Sensation 40 40
Arrhythmia 40 40
Muscle Weakness 37 38
Joint Contracture 36 36
Unspecified Tissue Injury 36 36
Staphylococcus Aureus 34 34
Low Blood Pressure/ Hypotension 31 31
Skin Discoloration 30 31
Skin Irritation 30 30
Purulent Discharge 30 30
Urinary Retention 29 29
Complaint, Ill-Defined 29 29
Deformity/ Disfigurement 29 29

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 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 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 Encore Medical, Lp II Dec-14-2016
30 Encore Medical, Lp II Dec-06-2016
31 Encore Medical, Lp II Oct-28-2016
32 Exactech, Inc. II Oct-04-2021
33 Exactech, Inc. II Feb-26-2020
34 Exactech, Inc. II Apr-23-2019
35 Exactech, Inc. II Sep-20-2018
36 Exactech, Inc. II Nov-20-2017
37 Exactech, Inc. II Jun-19-2017
38 Howmedica Osteonics Corp. II Aug-19-2021
39 Howmedica Osteonics Corp. II Apr-09-2021
40 Materialise USA LLC II Jun-09-2016
41 Medacta Usa Inc II Dec-20-2017
42 Medtronic Sofamor Danek USA Inc II Mar-21-2017
43 Medtronic Sofamor Danek USA Inc II Aug-23-2016
44 OMNIlife science Inc. II Mar-19-2018
45 Ortho Development Corporation II May-06-2020
46 Signature Orthopedics Pty Limited II Feb-14-2019
47 Smith & Nephew, Inc. II Jun-24-2021
48 Smith & Nephew, Inc. II Oct-16-2020
49 Smith & Nephew, Inc. II Aug-08-2020
50 Smith & Nephew, Inc. II Mar-17-2020
51 Smith & Nephew, Inc. II Sep-12-2019
52 Smith & Nephew, Inc. II Mar-22-2019
53 Smith & Nephew, Inc. II Oct-01-2018
54 Smith & Nephew, Inc. II Aug-22-2018
55 Smith & Nephew, Inc. II May-22-2018
56 Smith & Nephew, Inc. II Nov-16-2017
57 Smith & Nephew, Inc. II Jun-12-2017
58 Smith & Nephew, Inc. II Apr-21-2016
59 Smith & Nephew, Inc. II Feb-17-2016
60 Smith & Nephew, Inc. II Jan-04-2016
61 Stanmore Implants Worldwide Ltd. II May-09-2016
62 Stryker Howmedica Osteonics Corp. II Aug-09-2016
63 United Orthopedic Corporation II Mar-19-2018
64 Zimmer Biomet, Inc. II Nov-07-2019
65 Zimmer Biomet, Inc. II Sep-12-2019
66 Zimmer Biomet, Inc. II Apr-04-2019
67 Zimmer Biomet, Inc. II Feb-23-2019
68 Zimmer Biomet, Inc. II Dec-18-2018
69 Zimmer Biomet, Inc. II Nov-21-2018
70 Zimmer Biomet, Inc. II Sep-25-2018
71 Zimmer Biomet, Inc. II Jun-04-2018
72 Zimmer Biomet, Inc. II Jun-01-2018
73 Zimmer Biomet, Inc. II Jun-01-2018
74 Zimmer Biomet, Inc. II May-11-2018
75 Zimmer Biomet, Inc. II Mar-14-2018
76 Zimmer Biomet, Inc. II Feb-21-2018
77 Zimmer Biomet, Inc. II Feb-15-2018
78 Zimmer Biomet, Inc. II May-18-2017
79 Zimmer Biomet, Inc. II Mar-27-2017
80 Zimmer Biomet, Inc. II Feb-16-2017
81 Zimmer Biomet, Inc. II Jan-28-2017
82 Zimmer Biomet, Inc. II Oct-18-2016
83 Zimmer Biomet, Inc. II Oct-03-2016
84 Zimmer Biomet, Inc. II Feb-22-2016
85 Zimmer Manufacturing B.V. II Apr-06-2016
86 Zimmer Manufacturing B.V. II Mar-12-2016
87 Zimmer Manufacturing B.V. II Jan-05-2016
88 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
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