Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 8
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 7
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 DBA ENOVIS
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 3
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
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 3
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 9
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
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 4
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2018 14034 14034
2019 14986 14986
2020 12590 12590
2021 9406 9406
2022 8356 8356
2023 6024 6024

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 23717 23717
Insufficient Information 8154 8154
Fracture 6047 6047
Loss of or Failure to Bond 4559 4559
Appropriate Term/Code Not Available 3229 3229
Loosening of Implant Not Related to Bone-Ingrowth 3068 3068
Break 2970 2970
Naturally Worn 2538 2538
Unstable 2137 2137
Loose or Intermittent Connection 1491 1491
Detachment of Device or Device Component 1283 1283
Device Dislodged or Dislocated 1063 1063
Migration 981 981
Noise, Audible 784 784
Migration or Expulsion of Device 636 636
Patient Device Interaction Problem 590 590
Malposition of Device 492 492
Difficult to Insert 490 490
Component Missing 458 458
Loss of Osseointegration 412 412
Crack 402 402
Use of Device Problem 328 328
Scratched Material 308 308
Unintended Movement 303 303
Inadequacy of Device Shape and/or Size 272 272
Osseointegration Problem 255 255
Material Deformation 251 251
Physical Resistance/Sticking 231 231
Device Appears to Trigger Rejection 217 217
Tear, Rip or Hole in Device Packaging 215 215
Fitting Problem 195 195
Packaging Problem 188 188
Patient-Device Incompatibility 164 164
Material Twisted/Bent 161 161
Positioning Failure 159 159
Connection Problem 152 152
Device-Device Incompatibility 151 151
Mechanical Problem 150 150
Device Contaminated During Manufacture or Shipping 130 130
Disassembly 125 125
Corroded 121 121
Material Erosion 120 120
No Apparent Adverse Event 120 120
Failure to Cut 115 115
Device Slipped 110 110
Defective Device 99 99
Off-Label Use 94 94
Mechanical Jam 84 84
Improper or Incorrect Procedure or Method 76 76
Delivered as Unsterile Product 74 74
Device Damaged Prior to Use 67 67
Degraded 66 66
Material Integrity Problem 65 65
Difficult to Open or Remove Packaging Material 64 64
Failure To Adhere Or Bond 61 61
Positioning Problem 61 61
Material Discolored 58 58
Material Fragmentation 58 58
Defective Component 57 57
Manufacturing, Packaging or Shipping Problem 57 57
Incomplete or Inadequate Connection 51 51
Microbial Contamination of Device 47 47
Device Packaging Compromised 44 44
Illegible Information 42 42
Material Separation 41 41
Contamination 40 40
Biocompatibility 38 38
Contamination /Decontamination Problem 36 36
Failure to Align 36 36
Device Operates Differently Than Expected 36 36
Device Contamination with Chemical or Other Material 34 34
Device Markings/Labelling Problem 33 33
Nonstandard Device 32 32
Difficult to Advance 30 30
Expiration Date Error 29 29
Unsealed Device Packaging 29 29
Material Disintegration 27 27
Peeled/Delaminated 26 26
Difficult To Position 26 26
Residue After Decontamination 24 24
Material Too Rigid or Stiff 23 23
Product Quality Problem 22 22
Failure to Osseointegrate 22 22
Metal Shedding Debris 21 21
Inaccurate Information 21 21
Wrong Label 20 20
Incorrect Measurement 20 20
Difficult to Remove 19 19
Device Damaged by Another Device 19 19
Compatibility Problem 18 18
Unexpected Therapeutic Results 18 18
Material Rupture 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 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15839 15840
No Code Available 12895 12895
Unspecified Infection 9085 9085
No Clinical Signs, Symptoms or Conditions 5368 5368
Failure of Implant 4367 4367
No Information 3956 3956
Injury 3784 3784
No Consequences Or Impact To Patient 3242 3242
Joint Laxity 2830 2830
Insufficient Information 2448 2448
No Known Impact Or Consequence To Patient 2421 2421
Loss of Range of Motion 2190 2190
Adhesion(s) 1746 1746
No Patient Involvement 1564 1564
Swelling 1524 1524
Swelling/ Edema 1516 1516
Not Applicable 1512 1512
Bone Fracture(s) 1460 1461
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1430 1430
Limited Mobility Of The Implanted Joint 1278 1278
Ambulation Difficulties 1232 1232
Fall 1230 1230
Osteolysis 1150 1150
Joint Disorder 933 933
Muscular Rigidity 898 898
Edema 834 834
Synovitis 745 745
Joint Dislocation 698 699
Inadequate Osseointegration 638 638
Scar Tissue 611 611
Discomfort 597 597
Inflammation 551 551
Implant Pain 454 454
Thrombosis 450 450
Hematoma 421 421
Wound Dehiscence 394 394
Hypersensitivity/Allergic reaction 372 372
Impaired Healing 333 333
Reaction 328 328
Bacterial Infection 328 328
Fibrosis 322 322
Pulmonary Embolism 316 316
Tissue Damage 309 309
Unspecified Tissue Injury 308 308
Hemorrhage/Bleeding 271 271
Foreign Body Reaction 228 228
Cyst(s) 214 214
Thrombosis/Thrombus 177 177
Necrosis 167 167
Damage to Ligament(s) 152 152
Post Operative Wound Infection 150 150
Patient Problem/Medical Problem 149 149
Cellulitis 149 149
Osteopenia/ Osteoporosis 147 147
Metal Related Pathology 146 146
Muscle/Tendon Damage 139 139
Fluid Discharge 131 131
Limb Fracture 126 126
Numbness 125 125
Unspecified Musculoskeletal problem 123 123
Ossification 120 120
Sepsis 110 110
Foreign Body In Patient 108 108
Weakness 106 106
Rash 106 106
Anemia 105 105
Fatigue 100 100
Death 96 96
Nerve Damage 95 95
Erythema 92 92
Arthralgia 90 90
Blood Loss 80 80
Fever 77 77
Urinary Tract Infection 77 77
Scarring 77 77
Embolism 76 76
Burning Sensation 73 73
Pneumonia 73 73
Joint Contracture 73 73
Local Reaction 72 72
Rupture 70 70
Joint Swelling 63 63
Abscess 60 60
Aspiration/Inhalation 56 56
Arthritis 53 53
Myocardial Infarction 47 47
Deformity/ Disfigurement 47 47
Tingling 42 42
Muscle Weakness 40 40
Low Blood Pressure/ Hypotension 40 40
Subluxation 40 40
Alteration In Body Temperature 38 38
Neck Stiffness 37 37
Laceration(s) 36 36
Erosion 35 35
Urinary Retention 34 34
Embolism/Embolus 31 31
Chest Pain 30 30
Stroke/CVA 29 29
Arrhythmia 29 29

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 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 Encore Medical, Lp II Aug-31-2018
28 Encore Medical, Lp II Jan-10-2018
29 Exactech, Inc. II Oct-04-2021
30 Exactech, Inc. II Feb-26-2020
31 Exactech, Inc. II Apr-23-2019
32 Exactech, Inc. II Sep-20-2018
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 Linkbio Corp. II Jun-01-2023
37 Materialise N.V. II Jul-20-2023
38 OMNIlife science Inc. II Mar-19-2018
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 Jul-20-2022
44 Smith & Nephew, Inc. II Jun-24-2021
45 Smith & Nephew, Inc. II Oct-16-2020
46 Smith & Nephew, Inc. II Aug-08-2020
47 Smith & Nephew, Inc. II Mar-17-2020
48 Smith & Nephew, Inc. II Sep-12-2019
49 Smith & Nephew, Inc. II Mar-22-2019
50 Smith & Nephew, Inc. II Oct-01-2018
51 Smith & Nephew, Inc. II Aug-22-2018
52 Smith & Nephew, Inc. II May-22-2018
53 United Orthopedic Corporation II Mar-19-2018
54 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-03-2023
55 Waldemar Link GmbH & Co. KG (Mfg Site) II Jul-12-2022
56 Zimmer Biomet, Inc. II Nov-07-2019
57 Zimmer Biomet, Inc. II Sep-12-2019
58 Zimmer Biomet, Inc. II Apr-04-2019
59 Zimmer Biomet, Inc. II Feb-23-2019
60 Zimmer Biomet, Inc. II Dec-18-2018
61 Zimmer Biomet, Inc. II Nov-21-2018
62 Zimmer Biomet, Inc. II Sep-25-2018
63 Zimmer Biomet, Inc. II Jun-04-2018
64 Zimmer Biomet, Inc. II Jun-01-2018
65 Zimmer Biomet, Inc. II Jun-01-2018
66 Zimmer Biomet, Inc. II May-11-2018
67 Zimmer Biomet, Inc. II Mar-14-2018
68 Zimmer Biomet, Inc. II Feb-21-2018
69 Zimmer Biomet, Inc. II Feb-15-2018
70 Zimmer Trabecular Metal Technology, Inc. II Mar-11-2019
71 Zimmer, Inc. II Jul-05-2023
72 Zimmer, Inc. II Dec-09-2022
-
-