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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Product CodeLPH
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOCORE9, LLC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 3
BIOMET MANUFACTUTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 7
CARDO MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CONSENSUS ORTHOPEDICS, INC
  SUBSTANTIALLY EQUIVALENT 3
CONSENSUS ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 8
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTERNATIONAL, LTD
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 4
DEPUY ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ENCORE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 6
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 8
EXCERA ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
HOWMEDICA OSTEONICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 3
HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. (AKA STRYKER ORTHOPAEDICS)
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. A.K.A. STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP. AKA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 3
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
ICONACY ORTHOPEDIC IMPLANTS, LLC
  SUBSTANTIALLY EQUIVALENT 5
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 7
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC ADVANCED ENERGY
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVOSOURCE INC
  SUBSTANTIALLY EQUIVALENT 1
OMNI LIFE SCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 3
OMNILIFE SCIENCE INC.
  SUBSTANTIALLY EQUIVALENT 2
OMNLIFE SCIENCE
  SUBSTANTIALLY EQUIVALENT 3
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PIPELINE BIOTECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
PIPELINE ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 2
PRECISION CASTING SOLUTION, LLC
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENOVIS SURGICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS, PTY, LTD
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 17
STELKAST, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 4
TGM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TGM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE PROGRESSIVE ORTHOPAEDIC COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 2
THECKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
THEKEN COMPANIES
  SUBSTANTIALLY EQUIVALENT 1
THEKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 3
TOTAL JOINT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
UNITED ORTHOPEDIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 10
WALDEMAR LINK GMBH & CO KG
  SUBSTANTIALLY EQUIVALENT 1
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 9

MDR Year MDR Reports MDR Events
2014 5146 5146
2015 5805 5805
2016 4885 4885
2017 5306 5306
2018 5919 5919
2019 7116 7116
2020 5423 5423
2021 5983 5983
2022 5224 5224
2023 5377 5414
2024 2416 2416

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 16112 16134
Insufficient Information 11969 11969
Device Dislodged or Dislocated 9873 9888
Appropriate Term/Code Not Available 3612 3612
Naturally Worn 3047 3047
Loss of Osseointegration 2974 2974
Fracture 2795 2795
Corroded 2115 2115
Osseointegration Problem 1811 1811
Malposition of Device 1372 1372
Material Erosion 1366 1366
Degraded 1207 1207
Break 983 983
Noise, Audible 931 931
Disassembly 867 867
Unstable 803 803
Difficult to Insert 792 792
Loose or Intermittent Connection 747 747
Migration 700 700
Metal Shedding Debris 679 679
Migration or Expulsion of Device 674 674
Detachment of Device or Device Component 558 558
Use of Device Problem 538 538
Loosening of Implant Not Related to Bone-Ingrowth 405 405
Material Deformation 405 405
Biocompatibility 361 361
Device Contaminated During Manufacture or Shipping 357 357
Material Integrity Problem 357 357
Packaging Problem 323 323
Loss of or Failure to Bond 312 312
Mechanical Problem 307 307
Device Operates Differently Than Expected 306 306
Device Slipped 299 299
Positioning Problem 256 256
Difficult to Remove 238 238
Device-Device Incompatibility 214 214
Inadequacy of Device Shape and/or Size 179 179
Fitting Problem 164 164
Manufacturing, Packaging or Shipping Problem 161 161
Unintended Movement 156 156
Tear, Rip or Hole in Device Packaging 136 136
Separation Failure 123 123
Material Disintegration 122 122
Positioning Failure 119 119
Patient-Device Incompatibility 116 116
Failure to Osseointegrate 115 115
Detachment Of Device Component 114 114
Patient Device Interaction Problem 108 108
Failure To Adhere Or Bond 105 105
Material Separation 103 103
No Apparent Adverse Event 102 102
Material Discolored 85 85
Off-Label Use 77 77
Nonstandard Device 76 76
Device Contamination with Chemical or Other Material 74 74
Crack 66 66
Device Packaging Compromised 61 61
Scratched Material 59 59
Compatibility Problem 56 56
Separation Problem 55 55
Device Appears to Trigger Rejection 54 54
Improper or Incorrect Procedure or Method 46 46
Mechanical Jam 46 46
Material Twisted/Bent 45 45
Connection Problem 44 44
Material Fragmentation 42 42
Difficult To Position 39 39
Sticking 36 36
Device Markings/Labelling Problem 33 33
Defective Device 33 33
Bent 29 29
Physical Resistance/Sticking 28 28
Device Difficult to Setup or Prepare 27 27
Dull, Blunt 25 25
Component Missing 25 25
Difficult or Delayed Separation 25 25
Component Misassembled 25 25
Material Distortion 24 24
Material Protrusion/Extrusion 23 23
Device Damaged Prior to Use 23 23
Device Damaged by Another Device 23 23
Activation, Positioning or Separation Problem 21 21
Mechanics Altered 21 21
Contamination 20 20
Difficult to Advance 19 19
Contamination /Decontamination Problem 19 19
Difficult to Open or Remove Packaging Material 18 18
Entrapment of Device 17 17
Disconnection 17 17
Delivered as Unsterile Product 17 17
Component or Accessory Incompatibility 16 16
Delamination 15 15
Defective Component 15 15
Product Quality Problem 14 14
Failure to Align 13 13
Out-Of-Box Failure 11 11
Difficult or Delayed Positioning 11 11
Component Incompatible 11 11
Unsealed Device Packaging 10 10
Device Inoperable 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 17851 17851
No Code Available 10728 10728
Unspecified Infection 8745 8767
Joint Dislocation 6504 6519
No Information 6453 6453
Injury 5113 5113
Discomfort 3754 3754
Foreign Body Reaction 3633 3633
Inadequate Osseointegration 3286 3286
Inflammation 3061 3061
Insufficient Information 2679 2679
Bone Fracture(s) 2508 2508
Tissue Damage 2341 2341
Osteolysis 2135 2135
Ambulation Difficulties 2101 2101
Reaction 1906 1906
Metal Related Pathology 1827 1827
Joint Laxity 1687 1687
Test Result 1673 1673
Host-Tissue Reaction 1634 1634
Limited Mobility Of The Implanted Joint 1534 1534
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1524 1524
No Known Impact Or Consequence To Patient 1475 1475
Loss of Range of Motion 1455 1455
No Clinical Signs, Symptoms or Conditions 1435 1435
Fall 1412 1412
No Consequences Or Impact To Patient 1184 1184
Failure of Implant 1126 1126
Hypersensitivity/Allergic reaction 1091 1091
Not Applicable 1081 1081
Necrosis 905 905
Swelling 738 738
Swelling/ Edema 705 705
Unspecified Tissue Injury 683 683
Toxicity 619 619
Limb Fracture 543 543
Scar Tissue 527 527
Hematoma 514 514
Distress 501 501
Synovitis 488 488
Adhesion(s) 464 464
Ossification 463 463
Edema 416 416
Local Reaction 398 398
No Patient Involvement 395 395
Weakness 364 364
Fatigue 344 344
Cyst(s) 326 326
Muscle/Tendon Damage 312 312
Physical Asymmetry 273 273
Muscular Rigidity 263 263
Joint Disorder 249 249
Pulmonary Embolism 231 231
Hip Fracture 229 229
Hemorrhage/Bleeding 219 219
Fluid Discharge 208 208
Nerve Damage 204 204
Deformity/ Disfigurement 203 203
Anxiety 184 184
Osteopenia/ Osteoporosis 181 181
Cardiac Arrest 163 163
Infarction, Cerebral 155 155
Numbness 155 155
Depression 148 148
Thrombosis/Thrombus 146 146
Wound Dehiscence 145 145
Impaired Healing 142 142
Death 135 136
Foreign Body In Patient 133 133
Blood Loss 123 123
Joint Swelling 107 107
Hypoesthesia 105 105
Bacterial Infection 104 104
Rash 103 103
Fever 98 98
Post Operative Wound Infection 85 85
Sepsis 84 84
Unequal Limb Length 80 80
Fibrosis 79 79
Unspecified Musculoskeletal problem 78 78
Erythema 77 77
Abscess 77 77
Erosion 76 76
Complaint, Ill-Defined 76 76
Pocket Erosion 75 75
Myocardial Infarction 73 73
Thrombosis 72 72
Seroma 70 70
Device Embedded In Tissue or Plaque 69 69
Disability 65 65
Burning Sensation 59 59
Patient Problem/Medical Problem 57 57
Scarring 52 52
Anemia 48 48
Headache 48 48
Memory Loss/Impairment 47 47
Dizziness 47 47
Skin Irritation 45 45
Stroke/CVA 43 43
Non-union Bone Fracture 43 43

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-23-2023
2 Biomet, Inc. II Dec-17-2020
3 Biomet, Inc. II Aug-29-2015
4 Biomet, Inc. III Jun-11-2015
5 Biomet, Inc. II Feb-17-2015
6 Biomet, Inc. II Jun-05-2013
7 Biomet, Inc. II Jun-08-2011
8 Biomet, Inc. II May-26-2010
9 CORENTEC CO., LTD II Mar-13-2017
10 Conformis, Inc. II Nov-20-2020
11 Conformis, Inc. II Oct-08-2019
12 Conformis, Inc. II Jun-13-2019
13 Conformis, Inc. II Jan-12-2019
14 DePuy Orthopaedics, Inc. II May-22-2013
15 DePuy Orthopaedics, Inc. II Dec-20-2012
16 DePuy Orthopaedics, Inc. II Dec-19-2012
17 DePuy Orthopaedics, Inc. II Aug-17-2012
18 Djo Surgical II Mar-04-2014
19 Encore Medical, LP II Oct-12-2023
20 Encore Medical, LP II Oct-21-2022
21 Encore Medical, LP II Oct-20-2020
22 Encore Medical, LP II May-08-2020
23 Encore Medical, LP II Apr-10-2020
24 Encore Medical, Lp II Jul-19-2016
25 Exactech, Inc. II Jan-18-2024
26 Exactech, Inc. II Sep-09-2022
27 Exactech, Inc. II Jul-22-2021
28 Exactech, Inc. II Jan-17-2017
29 Exactech, Inc. II Feb-03-2014
30 Howmedica Osteonics Corp. II Apr-25-2024
31 Howmedica Osteonics Corp. II Feb-16-2022
32 Howmedica Osteonics Corp. II May-07-2020
33 Howmedica Osteonics Corp. II Nov-22-2019
34 Howmedica Osteonics Corp. II Mar-09-2018
35 Limacorporate S.p.A II Oct-21-2021
36 OMNIlife science Inc. II Oct-21-2019
37 OMNIlife science Inc. II Sep-05-2019
38 OMNIlife science Inc. II Jul-25-2018
39 OmniLife Science II Nov-16-2021
40 Omnilife Science Inc. II Aug-21-2015
41 Orthopedic Alliance LLC II May-24-2013
42 Signal Medical Corporation II Oct-22-2014
43 Smith & Nephew Inc II Dec-26-2013
44 Smith & Nephew Inc II Apr-21-2009
45 Smith & Nephew, Inc. II Mar-20-2019
46 Stryker Howmedica Osteonics Corp. II Jul-25-2016
47 Stryker Howmedica Osteonics Corp. II Nov-10-2015
48 Stryker Howmedica Osteonics Corp. II Sep-23-2015
49 Stryker Howmedica Osteonics Corp. II May-19-2015
50 Stryker Howmedica Osteonics Corp. II Mar-02-2010
51 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-26-2023
52 Wright Medical Technology Inc II Oct-31-2012
53 Zimmer Biomet, Inc. II Oct-06-2020
54 Zimmer Biomet, Inc. II Nov-22-2019
55 Zimmer Biomet, Inc. II Nov-07-2019
56 Zimmer Biomet, Inc. II Jul-05-2018
57 Zimmer Biomet, Inc. II Apr-27-2018
58 Zimmer Biomet, Inc. II Mar-14-2018
59 Zimmer Biomet, Inc. II Mar-14-2018
60 Zimmer Biomet, Inc. II Mar-09-2018
61 Zimmer Biomet, Inc. II Feb-26-2018
62 Zimmer Biomet, Inc. II Jan-04-2018
63 Zimmer Biomet, Inc. II Mar-20-2017
64 Zimmer Biomet, Inc. II Jan-13-2017
65 Zimmer Biomet, Inc. II Mar-04-2016
66 Zimmer Biomet, Inc. II Feb-22-2016
67 Zimmer Gmbh II Feb-20-2015
68 Zimmer Inc. II Jun-26-2015
69 Zimmer Inc. II Dec-01-2011
70 Zimmer Inc. II Oct-14-2010
71 Zimmer Inc. II Aug-26-2010
72 Zimmer Inc. II Aug-12-2010
73 Zimmer Inc. II Nov-13-2009
74 Zimmer Inc. II Jul-27-2009
75 Zimmer Manufacturing B.V. II May-16-2016
76 Zimmer Manufacturing B.V. II Mar-12-2016
77 Zimmer Manufacturing B.V. II Dec-24-2014
78 Zimmer Manufacturing B.V. II Dec-17-2014
79 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
80 Zimmer, Inc. II Mar-29-2023
81 Zimmer, Inc. II Jul-10-2014
82 Zimmer, Inc. II Jun-20-2014
83 Zimmer, Inc. II Apr-24-2014
84 Zimmer, Inc. II Feb-20-2014
85 Zimmer, Inc. II Oct-25-2013
86 Zimmer, Inc. II Feb-04-2013
87 Zimmer, Inc. II Nov-21-2012
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