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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 1
CPM MEDICAL CONSULTANTS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 3
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
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 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
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 8358 8358
2023 8983 8989
2024 3106 3300

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23400 23532
Fracture 5824 5824
Insufficient Information 4486 4486
Loss of or Failure to Bond 4112 4112
Loosening of Implant Not Related to Bone-Ingrowth 3181 3217
Naturally Worn 2949 2949
Appropriate Term/Code Not Available 2506 2506
Break 2460 2460
Unstable 1600 1600
Detachment of Device or Device Component 1256 1256
Device Dislodged or Dislocated 935 935
Migration 905 905
Loose or Intermittent Connection 748 748
Noise, Audible 594 594
Patient Device Interaction Problem 583 583
Difficult to Insert 476 476
Malposition of Device 376 376
Crack 366 366
Use of Device Problem 321 321
Device Appears to Trigger Rejection 312 312
Loss of Osseointegration 275 275
Component Missing 273 273
Scratched Material 260 260
Inadequacy of Device Shape and/or Size 249 249
Osseointegration Problem 238 238
Unintended Movement 238 238
Physical Resistance/Sticking 227 227
Tear, Rip or Hole in Device Packaging 219 219
Material Deformation 193 193
Positioning Failure 185 185
Packaging Problem 157 157
Material Twisted/Bent 152 152
Device Contaminated During Manufacture or Shipping 149 149
Device-Device Incompatibility 144 144
Fitting Problem 136 136
Connection Problem 130 130
Material Erosion 128 128
Patient-Device Incompatibility 122 122
No Apparent Adverse Event 119 119
Failure to Cut 115 115
Corroded 111 111
Migration or Expulsion of Device 110 110
Mechanical Problem 104 104
Off-Label Use 88 88
Mechanical Jam 75 75
Improper or Incorrect Procedure or Method 74 74
Delivered as Unsterile Product 72 72
Difficult to Open or Remove Packaging Material 71 71
Defective Device 69 69
Manufacturing, Packaging or Shipping Problem 67 67
Degraded 67 99
Device Damaged Prior to Use 62 62
Material Integrity Problem 56 56
Positioning Problem 54 54
Incomplete or Inadequate Connection 50 50
Material Fragmentation 44 44
Defective Component 43 43
Illegible Information 42 42
Device Slipped 39 39
Biocompatibility 36 36
Expiration Date Error 31 31
Contamination /Decontamination Problem 31 31
Difficult to Advance 31 31
Failure to Align 30 30
Unsealed Device Packaging 30 30
Nonstandard Device 28 28
Material Separation 27 27
Material Discolored 26 26
Peeled/Delaminated 24 24
Wrong Label 24 24
Device Markings/Labelling Problem 23 23
Failure to Osseointegrate 22 22
Inaccurate Information 22 22
Material Disintegration 21 21
Incorrect Measurement 19 19
Unexpected Therapeutic Results 18 18
Microbial Contamination of Device 17 17
Compatibility Problem 17 17
Product Quality Problem 16 16
Device Contamination with Chemical or Other Material 14 14
Material Protrusion/Extrusion 14 14
Therapeutic or Diagnostic Output Failure 14 14
Device Damaged by Another Device 13 13
Shipping Damage or Problem 13 13
Material Too Rigid or Stiff 13 13
Contamination 13 13
Collapse 12 12
Flaked 12 12
Material Rupture 12 12
Difficult to Remove 12 12
Incomplete or Missing Packaging 12 12
Material Split, Cut or Torn 10 10
Device Fell 8 8
Misassembled 8 8
Difficult or Delayed Positioning 8 8
Dent in Material 8 8
Entrapment of Device 7 7
Device Reprocessing Problem 6 6
Deformation Due to Compressive Stress 6 6
Device Handling Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 13588 13636
No Code Available 10929 10929
Unspecified Infection 8381 8381
No Clinical Signs, Symptoms or Conditions 6433 6433
Failure of Implant 5085 5085
Joint Laxity 3546 3546
Insufficient Information 3402 3552
Injury 2654 2654
Loss of Range of Motion 2200 2242
No Consequences Or Impact To Patient 2198 2198
Adhesion(s) 1769 1769
Swelling/ Edema 1751 1757
No Known Impact Or Consequence To Patient 1716 1716
No Information 1509 1509
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1443 1443
Bone Fracture(s) 1297 1297
No Patient Involvement 1187 1187
Ambulation Difficulties 1172 1174
Fall 1039 1039
Limited Mobility Of The Implanted Joint 1034 1034
Osteolysis 1015 1015
Muscular Rigidity 929 929
Swelling 878 878
Edema 737 737
Synovitis 704 704
Joint Dislocation 615 616
Scar Tissue 596 596
Inadequate Osseointegration 569 569
Discomfort 537 537
Joint Disorder 521 521
Implant Pain 494 494
Inflammation 491 491
Unspecified Tissue Injury 421 421
Hematoma 367 367
Wound Dehiscence 362 362
Hypersensitivity/Allergic reaction 345 345
Bacterial Infection 335 335
Thrombosis 318 318
Not Applicable 312 312
Fibrosis 280 280
Hemorrhage/Bleeding 275 275
Foreign Body Reaction 231 231
Pulmonary Embolism 227 227
Thrombosis/Thrombus 221 221
Impaired Healing 214 214
Tissue Damage 199 199
Metal Related Pathology 186 186
Reaction 182 182
Muscle/Tendon Damage 174 174
Limb Fracture 164 164
Necrosis 162 162
Cyst(s) 161 161
Damage to Ligament(s) 144 144
Osteopenia/ Osteoporosis 143 143
Fluid Discharge 142 142
Unspecified Musculoskeletal problem 135 135
Patient Problem/Medical Problem 125 125
Post Operative Wound Infection 119 119
Arthralgia 112 112
Ossification 111 111
Joint Contracture 103 103
Numbness 102 102
Fatigue 99 99
Anemia 94 94
Sepsis 90 90
Nerve Damage 85 85
Foreign Body In Patient 85 85
Erythema 80 80
Weakness 74 74
Local Reaction 69 69
Embolism 68 68
Scarring 67 67
Fever 64 64
Cellulitis 61 61
Rash 60 60
Burning Sensation 53 53
Abscess 53 53
Subluxation 53 53
Deformity/ Disfigurement 51 51
Erosion 51 51
Rupture 50 50
Pneumonia 47 47
Myocardial Infarction 44 44
Arthritis 43 43
Blood Loss 41 41
Muscle Weakness 40 40
Embolism/Embolus 37 37
Death 36 36
Low Blood Pressure/ Hypotension 36 36
Laceration(s) 35 35
Tingling 32 32
Stroke/CVA 29 29
Arrhythmia 29 29
Physical Asymmetry 27 27
Unequal Limb Length 27 27
Joint Swelling 26 26
Purulent Discharge 23 23
Dizziness 23 23
Urinary Retention 23 23
Itching Sensation 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 Conformis, Inc. II Apr-17-2024
7 Conformis, Inc. II Apr-08-2022
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 Corin Ltd II Nov-02-2023
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 Encore Medical, LP II Oct-12-2023
21 Encore Medical, LP II Sep-19-2023
22 Encore Medical, LP II Feb-27-2023
23 Encore Medical, LP II Jun-09-2022
24 Encore Medical, LP II Jul-20-2021
25 Encore Medical, LP II Apr-30-2021
26 Exactech, Inc. II Jan-18-2024
27 Exactech, Inc. II Oct-04-2021
28 Exactech, Inc. II Feb-26-2020
29 Exactech, Inc. II Apr-23-2019
30 Howmedica Osteonics Corp. II Jan-31-2024
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 Limacorporate S.p.A II Dec-09-2023
35 Linkbio Corp. II Jun-01-2023
36 Materialise N.V. II Jul-20-2023
37 Ortho Development Corporation II May-06-2020
38 Signature Orthopedics Pty Limited II Feb-14-2019
39 Smith & Nephew Inc II Sep-20-2023
40 Smith & Nephew Inc II May-16-2022
41 Smith & Nephew, Inc. II Oct-24-2023
42 Smith & Nephew, Inc. II Jul-20-2022
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 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-03-2023
50 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
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 Trabecular Metal Technology, Inc. II Mar-11-2019
56 Zimmer, Inc. II Apr-22-2024
57 Zimmer, Inc. II Jul-05-2023
58 Zimmer, Inc. II Dec-09-2022
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