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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
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 3
CORENTEC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 2
DEPUY INTERNATIONAL, LTD
  SUBSTANTIALLY EQUIVALENT 1
DEPUY IRELAND UC
  SUBSTANTIALLY EQUIVALENT 4
DEPUY ORTHOPAEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ENCORE MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
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 1
HOWMEDICA OSTEONICS CORP. DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC ADVANCED ENERGY
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRECISION CASTING SOLUTION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNATURE ORTHOPAEDICS PTY LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
STELKAST, INC.
  SUBSTANTIALLY EQUIVALENT 1
THECKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
THEKEN COMPANIES
  SUBSTANTIALLY EQUIVALENT 1
THEKEN COMPANIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
UNITED ORTHOPEDIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 2

MDR Year MDR Reports MDR Events
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 12397 12419
Device Dislodged or Dislocated 5455 5470
Insufficient Information 2159 2159
Naturally Worn 1575 1575
Fracture 1569 1569
Osseointegration Problem 1315 1315
Loss of Osseointegration 1232 1232
Material Erosion 1070 1070
Corroded 874 874
Degraded 756 756
Appropriate Term/Code Not Available 691 691
Difficult to Insert 617 617
Migration 602 602
Unstable 449 449
Detachment of Device or Device Component 445 445
Malposition of Device 405 405
Noise, Audible 388 388
Loosening of Implant Not Related to Bone-Ingrowth 353 353
Use of Device Problem 337 337
Device Contaminated During Manufacture or Shipping 329 329
Biocompatibility 272 272
Packaging Problem 193 193
Break 185 185
Device-Device Incompatibility 183 183
Loss of or Failure to Bond 168 168
Loose or Intermittent Connection 140 140
Difficult to Remove 125 125
Unintended Movement 122 122
Positioning Failure 114 114
Patient Device Interaction Problem 102 102
Manufacturing, Packaging or Shipping Problem 87 87
Positioning Problem 82 82
Tear, Rip or Hole in Device Packaging 81 81
Separation Failure 77 77
Material Deformation 76 76
Off-Label Use 70 70
No Apparent Adverse Event 65 65
Failure to Osseointegrate 58 58
Migration or Expulsion of Device 58 58
Mechanical Problem 53 53
Device Appears to Trigger Rejection 51 51
Inadequacy of Device Shape and/or Size 49 49
Nonstandard Device 38 38
Patient-Device Incompatibility 32 32
Difficult or Delayed Separation 24 24
Component Misassembled 24 24
Fitting Problem 24 24
Device Difficult to Setup or Prepare 23 23
Improper or Incorrect Procedure or Method 22 22
Separation Problem 22 22
Material Integrity Problem 22 22
Mechanical Jam 21 21
Material Twisted/Bent 20 20
Defective Device 20 20
Material Fragmentation 18 18
Crack 18 18
Difficult to Advance 18 18
Physical Resistance/Sticking 18 18
Activation, Positioning or Separation Problem 16 16
Device Markings/Labelling Problem 15 15
Material Discolored 14 14
Material Separation 13 13
Contamination /Decontamination Problem 13 13
Connection Problem 11 11
Device Damaged by Another Device 11 11
Material Disintegration 10 10
Device Slipped 9 9
Device Damaged Prior to Use 9 9
Shipping Damage or Problem 8 8
Difficult to Open or Remove Packaging Material 8 8
Device Contamination with Chemical or Other Material 8 8
Therapeutic or Diagnostic Output Failure 8 8
Scratched Material 7 7
Compatibility Problem 6 6
Illegible Information 6 6
Defective Component 6 6
Disconnection 6 6
Difficult or Delayed Positioning 6 6
Labelling, Instructions for Use or Training Problem 6 6
Delivered as Unsterile Product 5 5
Unsealed Device Packaging 5 5
Peeled/Delaminated 5 5
Inaccurate Information 5 5
Deformation Due to Compressive Stress 5 5
Wrong Label 4 4
Material Frayed 4 4
Component Missing 4 4
Failure to Align 4 4
Problem with Sterilization 4 4
Contamination 3 3
Device Reprocessing Problem 3 3
Device Misassembled During Manufacturing /Shipping 3 3
Output Problem 3 3
Installation-Related Problem 2 2
Missing Information 2 2
Failure to Disinfect 2 2
Entrapment of Device 2 2
Flaked 2 2
Pitted 2 2
Particulates 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8353 8353
No Code Available 5350 5350
Unspecified Infection 4729 4751
Joint Dislocation 4295 4310
Insufficient Information 2496 2496
Inadequate Osseointegration 2291 2291
Foreign Body Reaction 2098 2098
Injury 2020 2020
Metal Related Pathology 1639 1639
Joint Laxity 1582 1582
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1489 1489
No Clinical Signs, Symptoms or Conditions 1372 1372
Inflammation 1268 1268
Discomfort 1245 1245
Ambulation Difficulties 1196 1196
Bone Fracture(s) 1155 1155
Tissue Damage 1155 1155
Osteolysis 1140 1140
Test Result 936 936
Failure of Implant 895 895
Fall 868 868
Hypersensitivity/Allergic reaction 788 788
Reaction 748 748
Loss of Range of Motion 736 736
No Information 681 681
Swelling/ Edema 651 651
Unspecified Tissue Injury 631 631
Necrosis 574 574
Limited Mobility Of The Implanted Joint 567 567
Limb Fracture 497 497
No Known Impact Or Consequence To Patient 489 489
Scar Tissue 431 431
Adhesion(s) 380 380
Ossification 344 344
Hematoma 342 342
Distress 341 341
Local Reaction 307 307
Muscle/Tendon Damage 299 299
Synovitis 285 285
No Consequences Or Impact To Patient 280 280
Fatigue 270 270
Host-Tissue Reaction 269 269
Swelling 261 261
No Patient Involvement 256 256
Physical Asymmetry 242 242
Edema 238 238
Hemorrhage/Bleeding 197 197
Cyst(s) 192 192
Pulmonary Embolism 189 189
Nerve Damage 158 158
Muscular Rigidity 156 156
Fluid Discharge 148 148
Thrombosis/Thrombus 138 138
Deformity/ Disfigurement 135 135
Weakness 132 132
Osteopenia/ Osteoporosis 129 129
Anxiety 128 128
Cardiac Arrest 118 118
Wound Dehiscence 114 114
Impaired Healing 108 108
Depression 106 106
Joint Disorder 106 106
Infarction, Cerebral 106 106
Numbness 96 96
Hip Fracture 95 95
Not Applicable 91 91
Bacterial Infection 78 78
Foreign Body In Patient 71 71
Unequal Limb Length 70 70
Unspecified Musculoskeletal problem 69 69
Fever 69 69
Pocket Erosion 68 68
Sepsis 63 63
Hypoesthesia 63 63
Post Operative Wound Infection 62 62
Erythema 61 61
Rash 60 60
Blood Loss 60 60
Erosion 55 55
Myocardial Infarction 54 54
Thrombosis 54 54
Abscess 48 48
Death 44 44
Patient Problem/Medical Problem 44 44
Fibrosis 43 43
Seroma 42 42
Stroke/CVA 41 41
Implant Pain 39 39
Anemia 38 38
Memory Loss/Impairment 38 38
Dizziness 35 35
Pneumonia 32 32
Burning Sensation 30 30
Non-union Bone Fracture 29 29
Toxicity 28 28
Arrhythmia 28 28
Subluxation 26 26
Reaction to Medicinal Component of Device 24 24
Dyspnea 24 24
Headache 24 24

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Mar-23-2023
2 Biomet, Inc. II Dec-17-2020
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-12-2023
8 Encore Medical, LP II Oct-21-2022
9 Encore Medical, LP II Oct-20-2020
10 Encore Medical, LP II May-08-2020
11 Encore Medical, LP II Apr-10-2020
12 Exactech, Inc. II Jan-18-2024
13 Exactech, Inc. II Sep-09-2022
14 Exactech, Inc. II Jul-22-2021
15 Howmedica Osteonics Corp. II Feb-16-2022
16 Howmedica Osteonics Corp. II May-07-2020
17 Howmedica Osteonics Corp. II Nov-22-2019
18 Limacorporate S.p.A II Oct-21-2021
19 OMNIlife science Inc. II Oct-21-2019
20 OMNIlife science Inc. II Sep-05-2019
21 OmniLife Science II Nov-16-2021
22 Smith & Nephew, Inc. II Mar-20-2019
23 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-26-2023
24 Zimmer Biomet, Inc. II Oct-06-2020
25 Zimmer Biomet, Inc. II Nov-22-2019
26 Zimmer Biomet, Inc. II Nov-07-2019
27 Zimmer, Inc. II Mar-29-2023
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