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, 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 5917 5917
2019 7113 7113
2020 5423 5423
2021 5982 5982
2022 5224 5224
2023 5377 5414
2024 1368 1368

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15643 15665
Insufficient Information 11919 11919
Device Dislodged or Dislocated 9666 9681
Appropriate Term/Code Not Available 3611 3611
Naturally Worn 2969 2969
Loss of Osseointegration 2963 2963
Fracture 2748 2748
Corroded 2103 2103
Osseointegration Problem 1767 1767
Malposition of Device 1364 1364
Material Erosion 1326 1326
Degraded 1164 1164
Break 980 980
Noise, Audible 920 920
Disassembly 867 867
Unstable 795 795
Difficult to Insert 784 784
Loose or Intermittent Connection 747 747
Migration 687 687
Metal Shedding Debris 679 679
Migration or Expulsion of Device 673 673
Use of Device Problem 531 531
Detachment of Device or Device Component 529 529
Material Deformation 403 403
Loosening of Implant Not Related to Bone-Ingrowth 375 375
Biocompatibility 361 361
Material Integrity Problem 357 357
Device Contaminated During Manufacture or Shipping 354 354
Packaging Problem 318 318
Device Operates Differently Than Expected 306 306
Mechanical Problem 306 306
Loss of or Failure to Bond 304 304
Device Slipped 299 299
Positioning Problem 255 255
Difficult to Remove 236 236
Device-Device Incompatibility 207 207
Inadequacy of Device Shape and/or Size 177 177
Fitting Problem 164 164
Unintended Movement 155 155
Manufacturing, Packaging or Shipping Problem 154 154
Tear, Rip or Hole in Device Packaging 135 135
Material Disintegration 122 122
Positioning Failure 119 119
Separation Failure 117 117
Patient-Device Incompatibility 116 116
Detachment Of Device Component 114 114
Failure to Osseointegrate 111 111
Patient Device Interaction Problem 107 107
Failure To Adhere Or Bond 105 105
Material Separation 103 103
No Apparent Adverse Event 96 96
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 53 53
Device Appears to Trigger Rejection 52 52
Mechanical Jam 46 46
Improper or Incorrect Procedure or Method 45 45
Connection Problem 44 44
Material Twisted/Bent 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
Device Difficult to Setup or Prepare 27 27
Physical Resistance/Sticking 27 27
Difficult or Delayed Separation 25 25
Component Misassembled 25 25
Dull, Blunt 25 25
Component Missing 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
Mechanics Altered 21 21
Contamination 20 20
Difficult to Advance 19 19
Activation, Positioning or Separation Problem 19 19
Contamination /Decontamination Problem 19 19
Entrapment of Device 17 17
Disconnection 17 17
Delivered as Unsterile Product 17 17
Difficult to Open or Remove Packaging Material 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 17634 17634
No Code Available 10727 10727
Unspecified Infection 8562 8584
No Information 6453 6453
Joint Dislocation 6327 6342
Injury 5109 5109
Discomfort 3738 3738
Foreign Body Reaction 3577 3577
Inadequate Osseointegration 3231 3231
Inflammation 3049 3049
Insufficient Information 2501 2501
Bone Fracture(s) 2475 2475
Tissue Damage 2341 2341
Osteolysis 2095 2095
Ambulation Difficulties 2066 2066
Reaction 1902 1902
Metal Related Pathology 1736 1736
Test Result 1672 1672
Host-Tissue Reaction 1634 1634
Joint Laxity 1599 1599
Limited Mobility Of The Implanted Joint 1534 1534
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1521 1521
No Known Impact Or Consequence To Patient 1475 1475
Loss of Range of Motion 1438 1438
Fall 1391 1391
No Clinical Signs, Symptoms or Conditions 1377 1377
No Consequences Or Impact To Patient 1184 1184
Failure of Implant 1108 1108
Hypersensitivity/Allergic reaction 1085 1085
Not Applicable 1081 1081
Necrosis 894 894
Swelling 738 738
Swelling/ Edema 688 688
Unspecified Tissue Injury 671 671
Toxicity 619 619
Scar Tissue 517 517
Limb Fracture 500 500
Distress 499 499
Hematoma 498 498
Synovitis 483 483
Adhesion(s) 462 462
Ossification 451 451
Edema 416 416
Local Reaction 398 398
No Patient Involvement 395 395
Weakness 364 364
Fatigue 342 342
Cyst(s) 323 323
Muscle/Tendon Damage 305 305
Muscular Rigidity 257 257
Physical Asymmetry 250 250
Joint Disorder 249 249
Hip Fracture 228 228
Pulmonary Embolism 228 228
Hemorrhage/Bleeding 217 217
Deformity/ Disfigurement 202 202
Fluid Discharge 196 196
Nerve Damage 194 194
Anxiety 184 184
Osteopenia/ Osteoporosis 166 166
Cardiac Arrest 163 163
Infarction, Cerebral 155 155
Depression 148 148
Numbness 148 148
Thrombosis/Thrombus 139 139
Wound Dehiscence 135 135
Death 135 136
Impaired Healing 132 132
Foreign Body In Patient 130 130
Blood Loss 123 123
Joint Swelling 107 107
Hypoesthesia 105 105
Bacterial Infection 103 103
Rash 103 103
Fever 98 98
Sepsis 84 84
Post Operative Wound Infection 81 81
Fibrosis 79 79
Complaint, Ill-Defined 76 76
Erosion 76 76
Unspecified Musculoskeletal problem 76 76
Pocket Erosion 75 75
Abscess 74 74
Erythema 72 72
Thrombosis 72 72
Unequal Limb Length 70 70
Myocardial Infarction 69 69
Device Embedded In Tissue or Plaque 69 69
Disability 65 65
Seroma 64 64
Patient Problem/Medical Problem 57 57
Burning Sensation 56 56
Scarring 52 52
Headache 48 48
Anemia 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
-
-