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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
B-ONE ORTHO CORP.
  SUBSTANTIALLY EQUIVALENT 2
B-ONE ORTHO, CORP.
  SUBSTANTIALLY EQUIVALENT 4
BEIJING AK MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIORAD MEDISYS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS INC.
  SUBSTANTIALLY EQUIVALENT 7
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 3
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 3
HERAEUS MEDICAL GMBH
  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 6
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 3
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  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 7
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
SMITH&NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STABIL ORTHOPAEDIC SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
STELKAST, INC.
  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 2
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 5

MDR Year MDR Reports MDR Events
2018 14032 14032
2019 14989 14989
2020 12594 12594
2021 9440 9440
2022 8428 8428

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21267 21267
Insufficient Information 7658 7658
Fracture 5255 5255
Loss of or Failure to Bond 4256 4256
Appropriate Term/Code Not Available 3159 3159
Break 2950 2950
Loosening of Implant Not Related to Bone-Ingrowth 2664 2664
Unstable 2056 2056
Naturally Worn 1842 1842
Loose or Intermittent Connection 1488 1488
Detachment of Device or Device Component 1107 1107
Device Dislodged or Dislocated 972 972
Migration 914 914
Noise, Audible 753 753
Migration or Expulsion of Device 636 636
Patient Device Interaction Problem 564 564
Malposition of Device 481 481
Component Missing 457 457
Difficult to Insert 431 431
Loss of Osseointegration 406 406
Crack 399 399
Use of Device Problem 312 312
Scratched Material 302 302
Unintended Movement 290 290
Inadequacy of Device Shape and/or Size 254 254
Material Deformation 241 241
Osseointegration Problem 235 235
Physical Resistance/Sticking 231 231
Fitting Problem 194 194
Tear, Rip or Hole in Device Packaging 188 188
Material Twisted/Bent 159 159
Packaging Problem 158 158
Patient-Device Incompatibility 156 156
Connection Problem 152 152
Mechanical Problem 150 150
Device-Device Incompatibility 146 146
Positioning Failure 129 129
Disassembly 125 125
Device Contaminated During Manufacture or Shipping 119 119
Failure to Cut 117 117
Material Erosion 110 110
Corroded 110 110
Device Slipped 110 110
Defective Device 96 96
No Apparent Adverse Event 87 87
Device Appears to Trigger Rejection 86 86
Off-Label Use 85 85
Mechanical Jam 82 82
Delivered as Unsterile Product 70 70
Improper or Incorrect Procedure or Method 67 67
Failure To Adhere Or Bond 61 61
Degraded 60 60
Difficult to Open or Remove Packaging Material 59 59
Positioning Problem 58 58
Material Discolored 58 58
Material Fragmentation 58 58
Device Damaged Prior to Use 57 57
Defective Component 54 54
Material Integrity Problem 53 53
Manufacturing, Packaging or Shipping Problem 51 51
Incomplete or Inadequate Connection 51 51
Microbial Contamination of Device 47 47
Device Packaging Compromised 44 44
Material Separation 41 41
Illegible Information 41 41
Contamination 38 38
Device Operates Differently Than Expected 36 36
Contamination /Decontamination Problem 35 35
Device Contamination with Chemical or Other Material 34 34
Failure to Align 34 34
Device Markings/Labelling Problem 33 33
Difficult to Advance 30 30
Biocompatibility 30 30
Peeled/Delaminated 28 28
Material Disintegration 27 27
Nonstandard Device 26 26
Difficult To Position 26 26
Unsealed Device Packaging 26 26
Residue After Decontamination 24 24
Expiration Date Error 23 23
Material Too Rigid or Stiff 23 23
Metal Shedding Debris 21 21
Product Quality Problem 21 21
Incorrect Measurement 20 20
Difficult to Remove 19 19
Device Damaged by Another Device 19 19
Inaccurate Information 19 19
Compatibility Problem 18 18
Unexpected Therapeutic Results 18 18
Material Rupture 17 17
Failure to Osseointegrate 17 17
Deformation Due to Compressive Stress 17 17
Separation Problem 17 17
Collapse 15 15
Material Split, Cut or Torn 14 14
Therapeutic or Diagnostic Output Failure 13 13
Shipping Damage or Problem 13 13
Detachment Of Device Component 12 12
Dent in Material 11 11
Incomplete or Missing Packaging 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 14688 14689
No Code Available 12897 12897
Unspecified Infection 8322 8322
No Clinical Signs, Symptoms or Conditions 4307 4307
No Information 3956 3956
Injury 3784 3784
No Consequences Or Impact To Patient 3242 3242
Failure of Implant 3231 3231
No Known Impact Or Consequence To Patient 2421 2421
Joint Laxity 2237 2237
Loss of Range of Motion 1973 1973
Insufficient Information 1796 1796
Adhesion(s) 1614 1614
No Patient Involvement 1564 1564
Swelling 1526 1526
Not Applicable 1512 1512
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1375 1375
Bone Fracture(s) 1369 1370
Swelling/ Edema 1287 1287
Limited Mobility Of The Implanted Joint 1279 1279
Fall 1129 1129
Ambulation Difficulties 1110 1110
Osteolysis 1026 1026
Joint Disorder 932 932
Edema 834 834
Muscular Rigidity 810 810
Joint Dislocation 655 656
Synovitis 648 648
Inadequate Osseointegration 587 587
Discomfort 561 561
Scar Tissue 559 559
Inflammation 522 522
Thrombosis 450 450
Hematoma 410 410
Wound Dehiscence 364 364
Reaction 328 328
Fibrosis 313 313
Impaired Healing 309 309
Pulmonary Embolism 309 309
Tissue Damage 309 309
Hypersensitivity/Allergic reaction 303 303
Bacterial Infection 285 285
Implant Pain 283 283
Hemorrhage/Bleeding 229 229
Cyst(s) 207 207
Unspecified Tissue Injury 199 199
Foreign Body Reaction 197 197
Thrombosis/Thrombus 153 153
Patient Problem/Medical Problem 149 149
Necrosis 149 149
Cellulitis 147 147
Damage to Ligament(s) 140 140
Osteopenia/ Osteoporosis 138 138
Post Operative Wound Infection 138 138
Metal Related Pathology 127 127
Fluid Discharge 117 117
Muscle/Tendon Damage 116 116
Numbness 113 113
Ossification 111 111
Weakness 106 106
Foreign Body In Patient 102 102
Sepsis 100 100
Limb Fracture 98 98
Rash 97 97
Death 96 96
Fatigue 93 93
Anemia 90 90
Nerve Damage 83 83
Blood Loss 80 80
Erythema 79 79
Scarring 77 77
Urinary Tract Infection 77 77
Embolism 76 76
Unspecified Musculoskeletal problem 76 76
Fever 74 74
Local Reaction 71 71
Burning Sensation 68 68
Pneumonia 67 67
Rupture 63 63
Joint Contracture 63 63
Arthralgia 63 63
Joint Swelling 63 63
Abscess 59 59
Aspiration/Inhalation 56 56
Arthritis 49 49
Tingling 42 42
Myocardial Infarction 40 40
Muscle Weakness 40 40
Alteration In Body Temperature 38 38
Neck Stiffness 37 37
Deformity/ Disfigurement 37 37
Low Blood Pressure/ Hypotension 36 36
Urinary Retention 34 34
Embolism/Embolus 31 31
Erosion 30 30
Stroke/CVA 29 29
Chest Pain 28 28
Subluxation 28 28
Purulent Discharge 27 27
Arrhythmia 26 26

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 ConforMIS, Inc. II Oct-02-2018
7 ConforMIS, Inc. II Feb-13-2018
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 Exactech, Inc. II Oct-04-2021
28 Exactech, Inc. II Feb-26-2020
29 Exactech, Inc. II Apr-23-2019
30 Exactech, Inc. II Sep-20-2018
31 Howmedica Osteonics Corp. II Jun-03-2022
32 Howmedica Osteonics Corp. II Aug-19-2021
33 Howmedica Osteonics Corp. II Apr-09-2021
34 OMNIlife science Inc. II Mar-19-2018
35 Ortho Development Corporation II May-06-2020
36 Signature Orthopedics Pty Limited II Feb-14-2019
37 Smith & Nephew Inc II May-16-2022
38 Smith & Nephew, Inc. II Jul-20-2022
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 United Orthopedic Corporation II Mar-19-2018
49 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
50 Zimmer Biomet, Inc. II Nov-07-2019
51 Zimmer Biomet, Inc. II Sep-12-2019
52 Zimmer Biomet, Inc. II Apr-04-2019
53 Zimmer Biomet, Inc. II Feb-23-2019
54 Zimmer Biomet, Inc. II Dec-18-2018
55 Zimmer Biomet, Inc. II Nov-21-2018
56 Zimmer Biomet, Inc. II Sep-25-2018
57 Zimmer Biomet, Inc. II Jun-04-2018
58 Zimmer Biomet, Inc. II Jun-01-2018
59 Zimmer Biomet, Inc. II Jun-01-2018
60 Zimmer Biomet, Inc. II May-11-2018
61 Zimmer Biomet, Inc. II Mar-14-2018
62 Zimmer Biomet, Inc. II Feb-21-2018
63 Zimmer Biomet, Inc. II Feb-15-2018
64 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
65 Zimmer, Inc. II Dec-09-2022
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