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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 5
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 3
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 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
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 5
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 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 5
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 9425 9425

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 18185 18185
Insufficient Information 12357 12357
Fracture 5364 5364
Loss of or Failure to Bond 4551 4551
Break 3251 3251
Appropriate Term/Code Not Available 3144 3144
Unstable 2494 2494
Loosening of Implant Not Related to Bone-Ingrowth 2167 2167
Naturally Worn 1841 1841
Loose or Intermittent Connection 1749 1749
Migration or Expulsion of Device 1516 1516
Device Dislodged or Dislocated 1085 1085
Detachment of Device or Device Component 900 900
Noise, Audible 851 851
Migration 786 786
Component Missing 690 690
Malposition of Device 611 611
Loss of Osseointegration 588 588
Patient Device Interaction Problem 501 501
Difficult to Insert 442 442
Crack 406 406
Unintended Movement 329 329
Scratched Material 309 309
Use of Device Problem 293 293
Inadequacy of Device Shape and/or Size 286 286
Material Deformation 258 258
Disassembly 253 253
Failure To Adhere Or Bond 234 234
Physical Resistance/Sticking 231 231
Fitting Problem 230 230
Osseointegration Problem 208 208
Device Operates Differently Than Expected 193 193
Patient-Device Incompatibility 191 191
Packaging Problem 182 182
Device Slipped 177 177
Mechanical Problem 172 172
Connection Problem 167 167
Material Twisted/Bent 158 158
Device-Device Incompatibility 124 124
Device Contamination with Chemical or Other Material 117 117
Tear, Rip or Hole in Device Packaging 116 116
Corroded 112 112
Device Contaminated During Manufacture or Shipping 109 109
Material Erosion 108 108
Positioning Failure 100 100
Failure to Cut 98 98
Defective Device 96 96
Mechanical Jam 85 85
Improper or Incorrect Procedure or Method 82 82
Positioning Problem 79 79
Off-Label Use 74 74
Material Discolored 70 70
No Apparent Adverse Event 68 68
Device Packaging Compromised 66 66
Delivered as Unsterile Product 64 64
Difficult To Position 63 63
Contamination 63 63
Material Integrity Problem 62 62
Defective Component 61 61
Material Fragmentation 57 57
Microbial Contamination of Device 56 56
Detachment Of Device Component 55 55
Degraded 51 51
Material Separation 51 51
Manufacturing, Packaging or Shipping Problem 51 51
Incomplete or Inadequate Connection 51 51
Device Damaged Prior to Use 50 50
Failure to Align 46 46
Difficult to Open or Remove Packaging Material 46 46
Device Markings/Labelling Problem 45 45
Metal Shedding Debris 44 44
Peeled/Delaminated 40 40
Nonstandard Device 40 40
Illegible Information 40 40
Material Disintegration 33 33
Contamination /Decontamination Problem 33 33
Unsealed Device Packaging 31 31
Incorrect Measurement 30 30
Difficult to Remove 29 29
Biocompatibility 26 26
Difficult to Advance 26 26
Product Quality Problem 24 24
Material Too Rigid or Stiff 24 24
Residue After Decontamination 23 23
Device Damaged by Another Device 22 22
Bent 22 22
Expiration Date Error 20 20
Compatibility Problem 19 19
Deformation Due to Compressive Stress 18 18
Collapse 18 18
Material Rupture 18 18
Misconnection 18 18
Separation Problem 17 17
Device Appears to Trigger Rejection 15 15
Shipping Damage or Problem 14 14
Pitted 14 14
Incorrect Device Or Component Shipped 13 13
Material Split, Cut or Torn 12 12
Misassembled 12 12
Device Issue 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15550 15552
No Code Available 14219 14219
Unspecified Infection 8736 8736
No Information 7155 7155
Injury 4431 4431
No Consequences Or Impact To Patient 3707 3707
No Known Impact Or Consequence To Patient 3479 3480
No Clinical Signs, Symptoms or Conditions 2391 2391
Failure of Implant 2237 2237
Swelling 1901 1901
No Patient Involvement 1815 1815
Loss of Range of Motion 1759 1759
Limited Mobility Of The Implanted Joint 1555 1555
Not Applicable 1543 1543
Bone Fracture(s) 1506 1507
Adhesion(s) 1465 1465
Joint Laxity 1351 1351
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1294 1294
Joint Disorder 1187 1187
Osteolysis 1153 1153
Insufficient Information 1065 1065
Fall 1060 1061
Ambulation Difficulties 1015 1016
Edema 862 862
Swelling/ Edema 798 798
Joint Dislocation 742 743
Muscular Rigidity 664 664
Synovitis 587 587
Inadequate Osseointegration 546 546
Discomfort 538 538
Reaction 533 533
Thrombosis 506 506
Inflammation 483 483
Scar Tissue 443 443
Hematoma 425 425
Wound Dehiscence 340 340
Fibrosis 338 338
Tissue Damage 334 334
Hypersensitivity/Allergic reaction 317 317
Pulmonary Embolism 298 298
Impaired Healing 286 286
Implant Pain 240 240
Bacterial Infection 222 222
Death 206 206
Cyst(s) 202 202
Patient Problem/Medical Problem 196 196
Foreign Body Reaction 186 186
Hemorrhage/Bleeding 185 185
Necrosis 162 162
Joint Swelling 155 156
Damage to Ligament(s) 146 146
Cellulitis 145 145
Foreign Body In Patient 123 123
Rash 120 120
Post Operative Wound Infection 119 119
Weakness 114 114
Thrombosis/Thrombus 114 114
Numbness 113 113
Ossification 99 99
Blood Loss 97 97
Anemia 93 93
Burning Sensation 90 91
Sepsis 88 88
Rupture 83 83
Metal Related Pathology 82 82
Fever 82 82
Osteopenia/ Osteoporosis 81 81
Muscle/Tendon Damage 78 78
Fatigue 77 77
Embolism 77 77
Scarring 77 77
Nerve Damage 72 72
Urinary Tract Infection 70 70
Erythema 68 68
Limb Fracture 67 67
Local Reaction 66 66
Aspiration/Inhalation 64 64
Unspecified Tissue Injury 62 62
Fluid Discharge 62 62
Arthritis 58 58
Device Embedded In Tissue or Plaque 52 52
Arthralgia 50 50
Pneumonia 48 48
Alteration In Body Temperature 47 47
Tingling 46 46
Neck Stiffness 44 44
Abscess 44 44
Myocardial Infarction 43 43
Itching Sensation 41 41
Arrhythmia 40 40
Joint Contracture 39 39
Low Blood Pressure/ Hypotension 36 36
Muscle Weakness 36 37
Urinary Retention 30 30
Deformity/ Disfigurement 29 29
Staphylococcus Aureus 29 29
Purulent Discharge 28 28
Stroke/CVA 27 27
Chest Pain 27 27
Skin Irritation 27 27

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 Aug-22-2020
9 Conformis, Inc. II Apr-01-2020
10 Conformis, Inc. II Dec-12-2019
11 Conformis, Inc. II Apr-08-2019
12 Conformis, Inc. II Mar-30-2019
13 DePuy Orthopaedics, Inc. II Oct-07-2021
14 DePuy Orthopaedics, Inc. II Aug-25-2021
15 DePuy Orthopaedics, Inc. II Mar-29-2021
16 DePuy Orthopaedics, Inc. II Feb-09-2021
17 DePuy Orthopaedics, Inc. II Aug-29-2018
18 DePuy Orthopaedics, Inc. II Apr-30-2018
19 Encore Medical, LP II Jul-20-2021
20 Encore Medical, LP II Apr-30-2021
21 Encore Medical, Lp II Aug-31-2018
22 Encore Medical, Lp II Jan-10-2018
23 Encore Medical, Lp II Oct-20-2017
24 Encore Medical, Lp II Jun-30-2017
25 Encore Medical, Lp II Feb-03-2017
26 Exactech, Inc. II Oct-04-2021
27 Exactech, Inc. II Feb-26-2020
28 Exactech, Inc. II Apr-23-2019
29 Exactech, Inc. II Sep-20-2018
30 Exactech, Inc. II Nov-20-2017
31 Exactech, Inc. II Jun-19-2017
32 Howmedica Osteonics Corp. II Aug-19-2021
33 Howmedica Osteonics Corp. II Apr-09-2021
34 Medacta Usa Inc II Dec-20-2017
35 Medtronic Sofamor Danek USA Inc II Mar-21-2017
36 OMNIlife science Inc. II Mar-19-2018
37 Ortho Development Corporation II May-06-2020
38 Signature Orthopedics Pty Limited II Feb-14-2019
39 Smith & Nephew, Inc. II Jun-24-2021
40 Smith & Nephew, Inc. II Oct-16-2020
41 Smith & Nephew, Inc. II Aug-08-2020
42 Smith & Nephew, Inc. II Mar-17-2020
43 Smith & Nephew, Inc. II Sep-12-2019
44 Smith & Nephew, Inc. II Mar-22-2019
45 Smith & Nephew, Inc. II Oct-01-2018
46 Smith & Nephew, Inc. II Aug-22-2018
47 Smith & Nephew, Inc. II May-22-2018
48 Smith & Nephew, Inc. II Nov-16-2017
49 Smith & Nephew, Inc. II Jun-12-2017
50 United Orthopedic Corporation II Mar-19-2018
51 Zimmer Biomet, Inc. II Nov-07-2019
52 Zimmer Biomet, Inc. II Sep-12-2019
53 Zimmer Biomet, Inc. II Apr-04-2019
54 Zimmer Biomet, Inc. II Feb-23-2019
55 Zimmer Biomet, Inc. II Dec-18-2018
56 Zimmer Biomet, Inc. II Nov-21-2018
57 Zimmer Biomet, Inc. II Sep-25-2018
58 Zimmer Biomet, Inc. II Jun-04-2018
59 Zimmer Biomet, Inc. II Jun-01-2018
60 Zimmer Biomet, Inc. II Jun-01-2018
61 Zimmer Biomet, Inc. II May-11-2018
62 Zimmer Biomet, Inc. II Mar-14-2018
63 Zimmer Biomet, Inc. II Feb-21-2018
64 Zimmer Biomet, Inc. II Feb-15-2018
65 Zimmer Biomet, Inc. II May-18-2017
66 Zimmer Biomet, Inc. II Mar-27-2017
67 Zimmer Biomet, Inc. II Feb-16-2017
68 Zimmer Biomet, Inc. II Jan-28-2017
69 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
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