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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
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTERNATIONAL, LTD
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC ADVANCED ENERGY
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PRECISION CASTING SOLUTION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 10
STELKAST, INC.
  SUBSTANTIALLY EQUIVALENT 1
THECKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
THEKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
TOTAL JOINT OTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
WALDEMAR LINK GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 5294 5294
2018 5900 5900
2019 7086 7086
2020 5413 5413
2021 6001 6001
2022 3625 3625

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9647 9647
Device Dislodged or Dislocated 5609 5609
Insufficient Information 5504 5504
Loss of Osseointegration 1822 1822
Fracture 1624 1624
Appropriate Term/Code Not Available 1562 1562
Naturally Worn 1483 1483
Corroded 1282 1282
Osseointegration Problem 1166 1166
Material Erosion 1010 1010
Degraded 685 685
Malposition of Device 643 643
Difficult to Insert 563 563
Unstable 523 523
Migration 504 504
Break 474 474
Noise, Audible 391 391
Loose or Intermittent Connection 385 385
Migration or Expulsion of Device 382 382
Biocompatibility 352 352
Detachment of Device or Device Component 339 339
Device Contaminated During Manufacture or Shipping 335 335
Material Deformation 296 296
Use of Device Problem 271 271
Disassembly 258 258
Packaging Problem 223 223
Loosening of Implant Not Related to Bone-Ingrowth 221 221
Loss of or Failure to Bond 202 202
Metal Shedding Debris 166 166
Difficult to Remove 156 156
Device-Device Incompatibility 147 147
Positioning Problem 124 124
Unintended Movement 122 122
Mechanical Problem 119 119
Tear, Rip or Hole in Device Packaging 106 106
Inadequacy of Device Shape and/or Size 90 90
Failure to Osseointegrate 86 86
Separation Failure 85 85
Positioning Failure 80 80
Fitting Problem 79 79
Device Operates Differently Than Expected 76 76
Material Integrity Problem 62 62
Nonstandard Device 54 54
Material Disintegration 53 53
Patient Device Interaction Problem 51 51
Scratched Material 49 49
Separation Problem 48 48
Material Separation 47 47
Device Contamination with Chemical or Other Material 46 46
Patient-Device Incompatibility 46 46
Off-Label Use 45 45
Device Packaging Compromised 44 44
Manufacturing, Packaging or Shipping Problem 42 42
Detachment Of Device Component 41 41
Material Discolored 39 39
Crack 38 38
No Apparent Adverse Event 38 38
Failure To Adhere Or Bond 33 33
Device Slipped 33 33
Difficult To Position 31 31
Mechanical Jam 31 31
Material Fragmentation 27 27
Device Difficult to Setup or Prepare 26 26
Connection Problem 25 25
Component Misassembled 24 24
Difficult or Delayed Separation 23 23
Material Twisted/Bent 23 23
Material Distortion 23 23
Device Markings/Labelling Problem 22 22
Physical Resistance/Sticking 22 22
Device Damaged by Another Device 21 21
Improper or Incorrect Procedure or Method 21 21
Defective Device 19 19
Contamination /Decontamination Problem 18 18
Activation, Positioning or SeparationProblem 15 15
Disconnection 15 15
Bent 15 15
Compatibility Problem 14 14
Dull, Blunt 14 14
Component Missing 14 14
Delamination 12 12
Device Appears to Trigger Rejection 12 12
Contamination 11 11
Difficult or Delayed Positioning 11 11
Difficult to Open or Remove Packaging Material 11 11
Difficult to Advance 11 11
Shipping Damage or Problem 10 10
Delivered as Unsterile Product 9 9
Failure to Align 8 8
Therapeutic or Diagnostic Output Failure 8 8
Component Incompatible 7 7
Entrapment of Device 7 7
Labelling, Instructions for Use or Training Problem 7 7
Flaked 6 6
Unsealed Device Packaging 6 6
Device Damaged Prior to Use 6 6
Material Protrusion/Extrusion 6 6
Inaccurate Information 6 6
Microbial Contamination of Device 5 5
Problem with Sterilization 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 10105 10105
No Code Available 6910 6910
Unspecified Infection 4869 4869
Joint Dislocation 4423 4423
Injury 4063 4063
Inadequate Osseointegration 2594 2594
No Information 2008 2008
Discomfort 1914 1914
Foreign Body Reaction 1880 1880
Inflammation 1850 1850
Tissue Damage 1796 1796
Reaction 1529 1529
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1477 1477
Test Result 1436 1436
Bone Fracture(s) 1410 1410
Insufficient Information 1340 1340
Ambulation Difficulties 1139 1139
Osteolysis 1129 1129
Limited Mobility Of The Implanted Joint 1025 1025
Not Applicable 956 956
No Known Impact Or Consequence To Patient 904 904
Joint Laxity 817 817
No Consequences Or Impact To Patient 802 802
Fall 794 794
Loss of Range of Motion 745 745
No Clinical Signs, Symptoms or Conditions 745 745
Metal Related Pathology 734 734
Hypersensitivity/Allergic reaction 685 685
Host-Tissue Reaction 666 666
Failure of Implant 655 655
Necrosis 619 619
Swelling 477 477
Local Reaction 365 365
No Patient Involvement 355 355
Scar Tissue 347 347
Edema 333 333
Swelling/ Edema 333 333
Hematoma 329 329
Unspecified Tissue Injury 297 297
Adhesion(s) 292 292
Distress 289 289
Weakness 286 286
Ossification 284 284
Limb Fracture 257 257
Synovitis 244 244
Joint Disorder 199 199
Cyst(s) 191 191
Fatigue 191 191
Pulmonary Embolism 186 186
Hip Fracture 156 156
Hemorrhage/Bleeding 149 149
Infarction, Cerebral 144 144
Cardiac Arrest 143 143
Muscle/Tendon Damage 141 141
Nerve Damage 134 134
Physical Asymmetry 130 130
Deformity/ Disfigurement 121 121
Fluid Discharge 121 121
Blood Loss 113 113
Muscular Rigidity 113 113
Anxiety 105 105
Impaired Healing 101 101
Osteopenia/ Osteoporosis 94 94
Thrombosis/Thrombus 94 94
Death 94 94
Hypoesthesia 85 85
Wound Dehiscence 82 82
Numbness 76 76
Foreign Body In Patient 76 76
Depression 74 74
Rash 68 68
Thrombosis 66 66
Bacterial Infection 64 64
Erosion 64 64
Sepsis 62 62
Myocardial Infarction 60 60
Post Operative Wound Infection 60 60
Patient Problem/Medical Problem 56 56
Toxicity 51 51
Abscess 51 51
Fever 50 50
Pocket Erosion 45 45
Burning Sensation 45 45
Stroke/CVA 39 39
Unspecified Musculoskeletal problem 36 36
Device Embedded In Tissue or Plaque 35 35
Headache 35 35
Anemia 33 33
Dizziness 33 33
Memory Loss/Impairment 33 33
Fibrosis 33 33
Scarring 32 32
Pneumonia 31 31
Erythema 30 30
Unequal Limb Length 30 30
Neuropathy 28 28
Seroma 26 26
Skin Irritation 26 26
Muscle Spasm(s) 25 25
Arrhythmia 24 24

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 CORENTEC CO., LTD II Mar-13-2017
3 Conformis, Inc. II Nov-20-2020
4 Conformis, Inc. II Oct-08-2019
5 Conformis, Inc. II Jun-13-2019
6 Conformis, Inc. II Jan-12-2019
7 Encore Medical, LP II Oct-20-2020
8 Encore Medical, LP II May-08-2020
9 Encore Medical, LP II Apr-10-2020
10 Exactech, Inc. II Sep-09-2022
11 Exactech, Inc. II Jul-22-2021
12 Exactech, Inc. II Jan-17-2017
13 Howmedica Osteonics Corp. II Feb-16-2022
14 Howmedica Osteonics Corp. II May-07-2020
15 Howmedica Osteonics Corp. II Nov-22-2019
16 Howmedica Osteonics Corp. II Mar-09-2018
17 Limacorporate S.p.A II Oct-21-2021
18 OMNIlife science Inc. II Oct-21-2019
19 OMNIlife science Inc. II Sep-05-2019
20 OMNIlife science Inc. II Jul-25-2018
21 OmniLife Science II Nov-16-2021
22 Smith & Nephew, Inc. II Mar-20-2019
23 Zimmer Biomet, Inc. II Oct-06-2020
24 Zimmer Biomet, Inc. II Nov-22-2019
25 Zimmer Biomet, Inc. II Nov-07-2019
26 Zimmer Biomet, Inc. II Jul-05-2018
27 Zimmer Biomet, Inc. II Apr-27-2018
28 Zimmer Biomet, Inc. II Mar-14-2018
29 Zimmer Biomet, Inc. II Mar-14-2018
30 Zimmer Biomet, Inc. II Mar-09-2018
31 Zimmer Biomet, Inc. II Feb-26-2018
32 Zimmer Biomet, Inc. II Jan-04-2018
33 Zimmer Biomet, Inc. II Mar-20-2017
34 Zimmer Biomet, Inc. II Jan-13-2017
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