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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 3
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
DEPUY (IRELAND)
  SUBSTANTIALLY EQUIVALENT 2
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 2
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 7
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 3
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2016 7584 7584
2017 12262 12262
2018 14032 14032
2019 14996 14996
2020 12596 12596
2021 5002 5002

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16492 16492
Insufficient Information 14929 14929
Fracture 5510 5510
Loss of or Failure to Bond 4861 4861
Break 3726 3726
Appropriate Term/Code Not Available 3093 3093
Unstable 2679 2679
Loosening of Implant Not Related to Bone-Ingrowth 1964 1964
Naturally Worn 1955 1955
Loose or Intermittent Connection 1907 1907
Migration or Expulsion of Device 1756 1756
Device Dislodged or Dislocated 1139 1139
Noise, Audible 897 897
Detachment of Device or Device Component 797 797
Component Missing 797 797
Migration 723 723
Malposition of Device 699 699
Loss of Osseointegration 683 683
Failure To Adhere Or Bond 526 526
Difficult to Insert 480 480
Patient Device Interaction Problem 436 436
Crack 422 422
Disassembly 383 383
Inadequacy of Device Shape and/or Size 334 334
Unintended Movement 332 332
Scratched Material 321 321
Device Operates Differently Than Expected 314 314
Use of Device Problem 288 288
Device Slipped 277 277
Material Deformation 262 262
Fitting Problem 255 255
Physical Resistance/Sticking 229 229
Patient-Device Incompatibility 211 211
Osseointegration Problem 203 203
Mechanical Problem 201 201
Packaging Problem 190 190
Connection Problem 168 168
Material Integrity Problem 155 155
Material Twisted/Bent 152 152
Device Contamination with Chemical or Other Material 151 151
Material Erosion 130 130
Device-Device Incompatibility 124 124
Degraded 123 123
Corroded 120 120
Tear, Rip or Hole in Device Packaging 115 115
Positioning Problem 115 115
Detachment Of Device Component 103 103
Defective Device 98 98
Improper or Incorrect Procedure or Method 95 95
Positioning Failure 90 90
Material Discolored 88 88
Mechanical Jam 86 86
Device Contaminated During Manufacture or Shipping 82 82
Device Packaging Compromised 81 81
Peeled/Delaminated 80 80
Delivered as Unsterile Product 73 73
Contamination 71 71
Nonstandard Device 70 70
Difficult To Position 70 70
No Apparent Adverse Event 67 67
Material Separation 61 61
Defective Component 61 61
Material Fragmentation 57 57
Microbial Contamination of Device 56 56
Device Markings/Labelling Problem 56 56
Metal Shedding Debris 51 51
Off-Label Use 50 50
Incomplete or Inadequate Connection 50 50
Manufacturing, Packaging or Shipping Problem 49 49
Device Damaged Prior to Use 47 47
Failure to Align 47 47
Failure to Cut 43 43
Illegible Information 40 40
Difficult to Remove 37 37
Material Disintegration 36 36
Compatibility Problem 35 35
Contamination /Decontamination Problem 34 34
Incorrect Measurement 32 32
Material Too Rigid or Stiff 31 31
Bent 29 29
Unsealed Device Packaging 27 27
Device Damaged by Another Device 27 27
Difficult to Advance 25 25
Residue After Decontamination 24 24
Biocompatibility 23 23
Product Quality Problem 23 23
Collapse 22 22
Expiration Date Error 21 21
Misconnection 21 21
Component Incompatible 19 19
Difficult to Open or Remove Packaging Material 19 19
Deformation Due to Compressive Stress 18 18
Incorrect Device Or Component Shipped 18 18
Device Reprocessing Problem 17 17
Pitted 17 17
Device Issue 16 16
Separation Problem 16 16
Material Rupture 16 16
Leak/Splash 16 16
Misassembled 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 16484 16486
No Code Available 15460 15460
Unspecified Infection 9029 9029
No Information 8934 8934
Injury 4706 4706
No Known Impact Or Consequence To Patient 4381 4382
No Consequences Or Impact To Patient 4019 4019
Swelling 2115 2115
No Patient Involvement 1968 1968
Failure of Implant 1794 1794
Limited Mobility Of The Implanted Joint 1679 1679
Loss of Range of Motion 1585 1585
Bone Fracture(s) 1571 1572
Not Applicable 1562 1562
No Clinical Signs, Symptoms or Conditions 1375 1375
Osteolysis 1355 1355
Adhesion(s) 1340 1340
Joint Disorder 1225 1225
Fall 1046 1047
Ambulation Difficulties 981 982
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 900 900
Edema 873 873
Joint Laxity 839 839
Joint Dislocation 739 740
Reaction 623 623
Insufficient Information 601 601
Muscular Rigidity 577 577
Discomfort 567 567
Inadequate Osseointegration 528 528
Thrombosis 520 520
Synovitis 516 516
Inflammation 487 487
Swelling/ Edema 482 482
Hematoma 379 379
Scar Tissue 376 376
Tissue Damage 353 353
Fibrosis 351 351
Wound Dehiscence 300 300
Pulmonary Embolism 291 291
Hypersensitivity/Allergic reaction 284 284
Impaired Healing 271 271
Joint Swelling 239 240
Death 236 236
Implant Pain 219 219
Bacterial Infection 214 214
Cyst(s) 210 210
Foreign Body Reaction 206 206
Patient Problem/Medical Problem 203 203
Necrosis 160 160
Hemorrhage/Bleeding 155 155
Damage to Ligament(s) 149 149
Post Operative Wound Infection 149 149
Cellulitis 145 145
Foreign Body In Patient 131 131
Weakness 119 119
Rash 116 116
Numbness 108 108
Blood Loss 98 98
Burning Sensation 93 94
Ossification 91 91
Rupture 84 84
Thrombosis/Thrombus 82 82
Scarring 81 81
Embolism 78 78
Anemia 78 78
Fever 73 73
Sepsis 73 73
Urinary Tract Infection 72 72
Erythema 68 68
Osteopenia/ Osteoporosis 67 67
Nerve Damage 66 66
Aspiration/Inhalation 65 65
Device Embedded In Tissue or Plaque 63 63
Arthritis 58 58
Fatigue 54 54
Fluid Discharge 53 53
Muscle/Tendon Damage 52 52
Arthralgia 52 52
Local Reaction 52 52
Alteration In Body Temperature 50 50
Neck Stiffness 50 50
Tingling 47 47
Pneumonia 45 45
Abscess 45 45
Metal Related Pathology 44 44
Myocardial Infarction 43 43
Itching Sensation 42 42
Arrhythmia 37 37
Muscle Weakness 37 38
Unspecified Tissue Injury 36 36
Staphylococcus Aureus 34 34
Low Blood Pressure/ Hypotension 31 31
Joint Contracture 31 31
Purulent Discharge 30 30
Skin Discoloration 30 31
Skin Irritation 30 30
Urinary Retention 29 29
Test Result 29 29
Complaint, Ill-Defined 29 29
Peroneal Nerve Palsy 27 27

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 Mar-29-2021
17 DePuy Orthopaedics, Inc. II Feb-09-2021
18 DePuy Orthopaedics, Inc. II Aug-29-2018
19 DePuy Orthopaedics, Inc. II Apr-30-2018
20 Encore Medical, LP II Jul-20-2021
21 Encore Medical, LP II Apr-30-2021
22 Encore Medical, Lp II Aug-31-2018
23 Encore Medical, Lp II Jan-10-2018
24 Encore Medical, Lp II Oct-20-2017
25 Encore Medical, Lp II Jun-30-2017
26 Encore Medical, Lp II Feb-03-2017
27 Encore Medical, Lp II Dec-14-2016
28 Encore Medical, Lp II Dec-06-2016
29 Encore Medical, Lp II Oct-28-2016
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 Apr-09-2021
36 Materialise USA LLC II Jun-09-2016
37 Medacta Usa Inc II Dec-20-2017
38 Medtronic Sofamor Danek USA Inc II Mar-21-2017
39 Medtronic Sofamor Danek USA Inc II Aug-23-2016
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 Jun-24-2021
44 Smith & Nephew, Inc. II Oct-16-2020
45 Smith & Nephew, Inc. II Aug-08-2020
46 Smith & Nephew, Inc. II Mar-17-2020
47 Smith & Nephew, Inc. II Sep-12-2019
48 Smith & Nephew, Inc. II Mar-22-2019
49 Smith & Nephew, Inc. II Oct-01-2018
50 Smith & Nephew, Inc. II Aug-22-2018
51 Smith & Nephew, Inc. II May-22-2018
52 Smith & Nephew, Inc. II Nov-16-2017
53 Smith & Nephew, Inc. II Jun-12-2017
54 Smith & Nephew, Inc. II Apr-21-2016
55 Smith & Nephew, Inc. II Feb-17-2016
56 Smith & Nephew, Inc. II Jan-04-2016
57 Stanmore Implants Worldwide Ltd. II May-09-2016
58 Stryker Howmedica Osteonics Corp. II Aug-09-2016
59 United Orthopedic Corporation II Mar-19-2018
60 Zimmer Biomet, Inc. II Nov-07-2019
61 Zimmer Biomet, Inc. II Sep-12-2019
62 Zimmer Biomet, Inc. II Apr-04-2019
63 Zimmer Biomet, Inc. II Feb-23-2019
64 Zimmer Biomet, Inc. II Dec-18-2018
65 Zimmer Biomet, Inc. II Nov-21-2018
66 Zimmer Biomet, Inc. II Sep-25-2018
67 Zimmer Biomet, Inc. II Jun-04-2018
68 Zimmer Biomet, Inc. II Jun-01-2018
69 Zimmer Biomet, Inc. II Jun-01-2018
70 Zimmer Biomet, Inc. II May-11-2018
71 Zimmer Biomet, Inc. II Mar-14-2018
72 Zimmer Biomet, Inc. II Feb-21-2018
73 Zimmer Biomet, Inc. II Feb-15-2018
74 Zimmer Biomet, Inc. II May-18-2017
75 Zimmer Biomet, Inc. II Mar-27-2017
76 Zimmer Biomet, Inc. II Feb-16-2017
77 Zimmer Biomet, Inc. II Jan-28-2017
78 Zimmer Biomet, Inc. II Oct-18-2016
79 Zimmer Biomet, Inc. II Oct-03-2016
80 Zimmer Biomet, Inc. II Feb-22-2016
81 Zimmer Manufacturing B.V. II Apr-06-2016
82 Zimmer Manufacturing B.V. II Mar-12-2016
83 Zimmer Manufacturing B.V. II Jan-05-2016
84 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
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