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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
AMPLITUDE
  SUBSTANTIALLY EQUIVALENT 1
B-ONE ORTHO CORP.
  SUBSTANTIALLY EQUIVALENT 1
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 4
BEIJING CHUNLIZHENGDA MEDICAL INSTRUMENTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIORAD MEDISYS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 8
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 6
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CPM MEDICAL CONSULTANTS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 4
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P. (DBA ENOVIS)
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P. DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A
  SUBSTANTIALLY EQUIVALENT 4
MATERIALISE NV
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MAXX ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 4
MERIL HEALTHCARE PVT. LTD.
  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 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
PRECISION CASTING SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 5
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
SMITH&NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STABIL ORTHOPAEDIC SOLUTIONS, LLC
  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
TJC LIFE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNIK ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2019 14986 14986
2020 12590 12590
2021 9406 9406
2022 8360 8360
2023 8983 8989
2024 5145 5339

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 24071 24203
Fracture 5959 5959
Insufficient Information 4538 4538
Loss of or Failure to Bond 4183 4183
Naturally Worn 3666 3666
Loosening of Implant Not Related to Bone-Ingrowth 3444 3480
Appropriate Term/Code Not Available 2516 2516
Break 2463 2463
Unstable 1632 1632
Detachment of Device or Device Component 1288 1288
Device Dislodged or Dislocated 962 962
Migration 931 931
Loose or Intermittent Connection 748 748
Noise, Audible 604 604
Patient Device Interaction Problem 593 593
Difficult to Insert 489 489
Malposition of Device 385 385
Crack 366 366
Device Appears to Trigger Rejection 356 356
Use of Device Problem 323 323
Loss of Osseointegration 286 286
Component Missing 273 273
Scratched Material 260 260
Inadequacy of Device Shape and/or Size 250 250
Osseointegration Problem 242 242
Unintended Movement 240 240
Physical Resistance/Sticking 227 227
Tear, Rip or Hole in Device Packaging 224 224
Positioning Failure 195 195
Material Deformation 193 193
Packaging Problem 158 158
Device Contaminated During Manufacture or Shipping 153 153
Material Twisted/Bent 152 152
Device-Device Incompatibility 145 145
Fitting Problem 137 137
Material Erosion 130 130
Connection Problem 130 130
No Apparent Adverse Event 130 130
Patient-Device Incompatibility 127 127
Failure to Cut 115 115
Migration or Expulsion of Device 113 113
Corroded 111 111
Mechanical Problem 104 104
Off-Label Use 91 91
Delivered as Unsterile Product 76 76
Mechanical Jam 76 76
Improper or Incorrect Procedure or Method 75 75
Difficult to Open or Remove Packaging Material 72 72
Defective Device 70 70
Manufacturing, Packaging or Shipping Problem 67 67
Degraded 67 99
Device Damaged Prior to Use 63 63
Material Integrity Problem 56 56
Positioning Problem 55 55
Incomplete or Inadequate Connection 50 50
Biocompatibility 46 46
Material Fragmentation 44 44
Defective Component 43 43
Illegible Information 42 42
Device Slipped 39 39
Unsealed Device Packaging 33 33
Expiration Date Error 31 31
Contamination /Decontamination Problem 31 31
Difficult to Advance 31 31
Failure to Align 30 30
Nonstandard Device 28 28
Material Separation 27 27
Material Discolored 26 26
Device Markings/Labelling Problem 26 26
Peeled/Delaminated 25 25
Wrong Label 24 24
Inaccurate Information 22 22
Failure to Osseointegrate 22 22
Material Disintegration 21 21
Incorrect Measurement 19 19
Microbial Contamination of Device 18 18
Unexpected Therapeutic Results 18 18
Product Quality Problem 17 17
Compatibility Problem 17 17
Therapeutic or Diagnostic Output Failure 14 14
Material Protrusion/Extrusion 14 14
Device Contamination with Chemical or Other Material 14 14
Contamination 14 14
Shipping Damage or Problem 13 13
Material Too Rigid or Stiff 13 13
Device Damaged by Another Device 13 13
Material Rupture 12 12
Difficult to Remove 12 12
Incomplete or Missing Packaging 12 12
Collapse 12 12
Flaked 12 12
Material Split, Cut or Torn 10 10
Deformation Due to Compressive Stress 9 9
Dent in Material 8 8
Misassembled 8 8
Difficult or Delayed Positioning 8 8
Device Fell 8 8
Entrapment of Device 7 7
Device Reprocessing Problem 6 6
Device Handling Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 14044 14092
No Code Available 10929 10929
Unspecified Infection 8614 8614
No Clinical Signs, Symptoms or Conditions 6616 6616
Failure of Implant 5747 5747
Joint Laxity 3838 3838
Insufficient Information 3686 3836
Injury 2654 2654
Loss of Range of Motion 2313 2355
No Consequences Or Impact To Patient 2198 2198
Swelling/ Edema 2001 2007
Adhesion(s) 1789 1789
No Known Impact Or Consequence To Patient 1716 1716
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1638 1638
No Information 1509 1509
Bone Fracture(s) 1322 1322
Ambulation Difficulties 1282 1284
Osteolysis 1205 1205
No Patient Involvement 1187 1187
Fall 1065 1065
Limited Mobility Of The Implanted Joint 1034 1034
Muscular Rigidity 952 952
Swelling 878 878
Synovitis 833 833
Implant Pain 744 744
Edema 737 737
Scar Tissue 642 642
Joint Dislocation 631 632
Discomfort 620 620
Inadequate Osseointegration 578 578
Joint Disorder 521 521
Inflammation 510 510
Unspecified Tissue Injury 445 445
Hematoma 377 377
Wound Dehiscence 370 370
Hypersensitivity/Allergic reaction 360 360
Bacterial Infection 337 337
Thrombosis 318 318
Not Applicable 312 312
Fibrosis 283 283
Hemorrhage/Bleeding 277 277
Thrombosis/Thrombus 245 245
Pulmonary Embolism 236 236
Foreign Body Reaction 232 232
Impaired Healing 219 219
Tissue Damage 199 199
Metal Related Pathology 196 196
Reaction 182 182
Muscle/Tendon Damage 179 179
Cyst(s) 167 167
Limb Fracture 164 164
Necrosis 162 162
Osteopenia/ Osteoporosis 157 157
Damage to Ligament(s) 152 152
Fluid Discharge 147 147
Unspecified Musculoskeletal problem 141 141
Patient Problem/Medical Problem 125 125
Post Operative Wound Infection 123 123
Arthralgia 120 120
Ossification 111 111
Numbness 107 107
Joint Contracture 103 103
Fatigue 99 99
Anemia 94 94
Nerve Damage 91 91
Sepsis 91 91
Foreign Body In Patient 85 85
Erythema 81 81
Weakness 74 74
Local Reaction 69 69
Embolism 68 68
Scarring 67 67
Fever 64 64
Cellulitis 62 62
Subluxation 61 61
Rash 60 60
Erosion 56 56
Abscess 54 54
Burning Sensation 54 54
Deformity/ Disfigurement 53 53
Rupture 52 52
Arthritis 52 52
Pneumonia 51 51
Muscle Weakness 50 50
Myocardial Infarction 44 44
Balance Problems 44 44
Blood Loss 41 41
Embolism/Embolus 37 37
Death 36 36
Low Blood Pressure/ Hypotension 36 36
Laceration(s) 35 35
Physical Asymmetry 34 34
Tingling 32 32
Emotional Changes 31 31
Unequal Limb Length 31 31
Stroke/CVA 29 29
Arrhythmia 29 29
Joint Swelling 26 26
Hyperextension 23 23
Purulent Discharge 23 23

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Mar-13-2020
2 Biomet, Inc. II Jan-30-2023
3 Biomet, Inc. II Dec-23-2020
4 Biomet, Inc. II May-28-2020
5 Biomet, Inc. II Apr-03-2020
6 CORENTEC CO., LTD II May-31-2024
7 Conformis, Inc. II Apr-17-2024
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-02-2023
15 Corin Ltd II Nov-21-2022
16 DePuy Orthopaedics, Inc. II Feb-09-2022
17 DePuy Orthopaedics, Inc. II Oct-07-2021
18 DePuy Orthopaedics, Inc. II Aug-25-2021
19 DePuy Orthopaedics, Inc. II Mar-29-2021
20 DePuy Orthopaedics, Inc. II Feb-09-2021
21 Encore Medical, LP II Oct-12-2023
22 Encore Medical, LP II Sep-19-2023
23 Encore Medical, LP II Feb-27-2023
24 Encore Medical, LP II Jun-09-2022
25 Encore Medical, LP II Jul-20-2021
26 Encore Medical, LP II Apr-30-2021
27 Exactech, Inc. II Jun-18-2024
28 Exactech, Inc. II Jan-18-2024
29 Exactech, Inc. II Oct-04-2021
30 Exactech, Inc. II Feb-26-2020
31 Exactech, Inc. II Apr-23-2019
32 Howmedica Osteonics Corp. II Jan-31-2024
33 Howmedica Osteonics Corp. II Jun-03-2022
34 Howmedica Osteonics Corp. II Aug-19-2021
35 Howmedica Osteonics Corp. II Apr-09-2021
36 Limacorporate S.p.A II Dec-09-2023
37 Linkbio Corp. II Jun-01-2023
38 Materialise N.V. II Jul-20-2023
39 Ortho Development Corporation II May-06-2020
40 Signature Orthopedics Pty Limited II Feb-14-2019
41 Smith & Nephew Inc II Sep-20-2023
42 Smith & Nephew Inc II May-16-2022
43 Smith & Nephew, Inc. II Oct-24-2023
44 Smith & Nephew, Inc. II Jul-20-2022
45 Smith & Nephew, Inc. II Jun-24-2021
46 Smith & Nephew, Inc. II Oct-16-2020
47 Smith & Nephew, Inc. II Aug-08-2020
48 Smith & Nephew, Inc. II Mar-17-2020
49 Smith & Nephew, Inc. II Sep-12-2019
50 Smith & Nephew, Inc. II Mar-22-2019
51 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-18-2024
52 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-03-2023
53 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
54 Zimmer Biomet, Inc. II Nov-07-2019
55 Zimmer Biomet, Inc. II Sep-12-2019
56 Zimmer Biomet, Inc. II Apr-04-2019
57 Zimmer Biomet, Inc. II Feb-23-2019
58 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
59 Zimmer, Inc. II Apr-22-2024
60 Zimmer, Inc. II Jul-05-2023
61 Zimmer, Inc. II Dec-09-2022
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