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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product CodeLPH
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
CONFORMIS, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 4
CORIN USA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ICONACY
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 2
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STELKAST
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2016 4877 4877
2017 5292 5292
2018 5886 5886
2019 7079 7079
2020 5380 5380
2021 1357 1357

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 6897 6897
Adverse Event Without Identified Device or Use Problem 6287 6287
Device Dislodged or Dislocated 4953 4953
Appropriate Term/Code Not Available 2098 2098
Loss of Osseointegration 2061 2061
Fracture 1427 1427
Corroded 1292 1292
Naturally Worn 1205 1205
Osseointegration Problem 797 797
Malposition of Device 785 785
Material Erosion 752 752
Break 660 660
Degraded 519 519
Migration or Expulsion of Device 491 491
Disassembly 465 465
Loose or Intermittent Connection 453 453
Difficult to Insert 438 438
Unstable 435 435
Noise, Audible 427 427
Biocompatibility 339 339
Material Deformation 336 336
Device Contaminated During Manufacture or Shipping 307 307
Migration 285 285
Metal Shedding Debris 269 269
Material Integrity Problem 228 228
Use of Device Problem 212 212
Mechanical Problem 206 206
Packaging Problem 204 204
Detachment of Device or Device Component 199 199
Positioning Problem 158 158
Difficult to Remove 150 150
Loss of or Failure to Bond 136 136
Device Operates Differently Than Expected 128 128
Device-Device Incompatibility 118 118
Loosening of Implant Not Related to Bone-Ingrowth 106 106
Fitting Problem 103 103
Inadequacy of Device Shape and/or Size 100 100
Unintended Movement 98 98
Tear, Rip or Hole in Device Packaging 84 84
Device Slipped 81 81
Detachment Of Device Component 76 76
Failure to Osseointegrate 75 75
Separation Failure 71 71
Material Disintegration 69 69
Material Separation 65 65
Nonstandard Device 65 65
Device Contamination with Chemical or Other Material 63 63
Failure To Adhere Or Bond 62 62
Manufacturing, Packaging or Shipping Problem 61 61
Positioning Failure 56 56
Material Discolored 55 55
Patient-Device Incompatibility 53 53
Device Packaging Compromised 53 53
Scratched Material 51 51
Separation Problem 47 47
Crack 43 43
No Apparent Adverse Event 37 37
Difficult To Position 36 36
Material Fragmentation 30 30
Mechanical Jam 30 30
Device Markings/Labelling Problem 28 28
Connection Problem 26 26
Patient Device Interaction Problem 26 26
Material Twisted/Bent 25 25
Dull, Blunt 25 25
Material Distortion 23 23
Component Misassembled 23 23
Bent 21 21
Device Difficult to Setup or Prepare 21 21
Device Damaged by Another Device 21 21
Difficult or Delayed Separation 20 20
Defective Device 18 18
Component Missing 18 18
Physical Resistance/Sticking 18 18
Compatibility Problem 18 18
Contamination /Decontamination Problem 18 18
Improper or Incorrect Procedure or Method 18 18
Sticking 16 16
Disconnection 16 16
Component or Accessory Incompatibility 16 16
Off-Label Use 16 16
Delamination 13 13
Contamination 13 13
Delivered as Unsterile Product 13 13
Product Quality Problem 12 12
Device Damaged Prior to Use 12 12
Entrapment of Device 12 12
Mechanics Altered 12 12
Material Protrusion/Extrusion 12 12
Activation, Positioning or SeparationProblem 11 11
Difficult or Delayed Positioning 11 11
Shipping Damage or Problem 10 10
Out-Of-Box Failure 9 9
Difficult to Open or Remove Packaging Material 9 9
Failure to Align 8 8
Defective Component 8 8
Device Appears to Trigger Rejection 8 8
Misconnection 7 7
Labelling, Instructions for Use or Training Problem 7 7
Component Incompatible 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 9641 9641
No Code Available 7700 7700
Injury 4641 4641
Unspecified Infection 4312 4312
Joint Dislocation 3551 3551
No Information 3310 3310
Discomfort 2157 2157
Inadequate Osseointegration 2119 2119
Tissue Damage 1907 1907
Inflammation 1893 1893
Foreign Body Reaction 1676 1676
Reaction 1670 1670
Test Result 1455 1455
Bone Fracture(s) 1404 1404
Limited Mobility Of The Implanted Joint 1251 1251
No Known Impact Or Consequence To Patient 1186 1186
No Consequences Or Impact To Patient 1054 1054
Osteolysis 1004 1004
Not Applicable 1003 1003
Host-Tissue Reaction 945 945
Ambulation Difficulties 789 789
Fall 580 580
Loss of Range of Motion 546 546
Hypersensitivity/Allergic reaction 541 541
Swelling 527 527
Necrosis 523 523
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 431 431
No Patient Involvement 379 379
Edema 366 366
Local Reaction 344 344
Weakness 311 311
Insufficient Information 310 310
Failure of Implant 301 301
Hematoma 245 245
Joint Disorder 221 221
Synovitis 195 195
Adhesion(s) 190 190
Ossification 187 187
Scar Tissue 177 177
Cyst(s) 170 170
No Clinical Signs, Symptoms or Conditions 170 170
Hip Fracture 168 168
Joint Laxity 158 158
Distress 150 150
Pulmonary Embolism 150 150
Infarction, Cerebral 145 145
Cardiac Arrest 133 133
Blood Loss 117 117
Fatigue 115 115
Death 108 108
Anxiety 100 100
Muscular Rigidity 99 99
Hypoesthesia 93 93
Toxicity 90 90
Deformity/ Disfigurement 85 85
Metal Related Pathology 72 72
Depression 70 70
Foreign Body In Patient 69 69
Thrombosis 68 68
Hemorrhage/Bleeding 66 66
Nerve Damage 66 66
Rash 65 65
Joint Swelling 63 63
Wound Dehiscence 59 59
Patient Problem/Medical Problem 56 56
Erosion 55 55
Osteopenia/ Osteoporosis 55 55
Device Embedded In Tissue or Plaque 51 51
Sepsis 50 50
Numbness 49 49
Abscess 45 45
Swelling/ Edema 45 45
Impaired Healing 44 44
Myocardial Infarction 44 44
Burning Sensation 41 41
Scarring 36 36
Fibrosis 36 36
Skin Irritation 35 35
Headache 34 34
Fever 32 32
Bacterial Infection 31 31
Pocket Erosion 31 31
Irritation 29 29
Stroke/CVA 28 28
Neuropathy 27 27
Memory Loss/Impairment 26 26
Unspecified Tissue Injury 26 26
Muscle Spasm(s) 25 25
Reaction to Medicinal Component of Device 23 23
Pneumonia 23 23
Seroma 23 23
Physical Asymmetry 22 22
Fluid Discharge 22 22
Aspiration/Inhalation 22 22
Arthritis 21 21
Sleep Dysfunction 21 21
Post Operative Wound Infection 21 21
Dizziness 20 20
Calcium Deposits/Calcification 20 20
Muscle Weakness 19 19

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 Encore Medical, Lp II Jul-19-2016
11 Exactech, Inc. II Jan-17-2017
12 Howmedica Osteonics Corp. II May-07-2020
13 Howmedica Osteonics Corp. II Nov-22-2019
14 Howmedica Osteonics Corp. II Mar-09-2018
15 OMNIlife science Inc. II Oct-21-2019
16 OMNIlife science Inc. II Sep-05-2019
17 OMNIlife science Inc. II Jul-25-2018
18 Smith & Nephew, Inc. II Mar-20-2019
19 Stryker Howmedica Osteonics Corp. II Jul-25-2016
20 Zimmer Biomet, Inc. II Oct-06-2020
21 Zimmer Biomet, Inc. II Nov-22-2019
22 Zimmer Biomet, Inc. II Nov-07-2019
23 Zimmer Biomet, Inc. II Jul-05-2018
24 Zimmer Biomet, Inc. II Apr-27-2018
25 Zimmer Biomet, Inc. II Mar-14-2018
26 Zimmer Biomet, Inc. II Mar-14-2018
27 Zimmer Biomet, Inc. II Mar-09-2018
28 Zimmer Biomet, Inc. II Feb-26-2018
29 Zimmer Biomet, Inc. II Jan-04-2018
30 Zimmer Biomet, Inc. II Mar-20-2017
31 Zimmer Biomet, Inc. II Jan-13-2017
32 Zimmer Biomet, Inc. II Mar-04-2016
33 Zimmer Biomet, Inc. II Feb-22-2016
34 Zimmer Manufacturing B.V. II May-16-2016
35 Zimmer Manufacturing B.V. II Mar-12-2016
36 Zimmer Trabecular Metal Technology, Inc. II Jun-10-2016
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