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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 7118 7118
2020 5423 5423
2021 5983 5983
2022 5224 5224
2023 5377 5414
2024 2946 2946

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13140 13162
Device Dislodged or Dislocated 5757 5772
Insufficient Information 2230 2230
Naturally Worn 1680 1680
Fracture 1633 1633
Osseointegration Problem 1384 1384
Loss of Osseointegration 1243 1243
Material Erosion 1130 1130
Corroded 892 892
Degraded 814 814
Appropriate Term/Code Not Available 693 693
Difficult to Insert 639 639
Migration 619 619
Detachment of Device or Device Component 480 480
Unstable 459 459
Malposition of Device 414 414
Noise, Audible 403 403
Loosening of Implant Not Related to Bone-Ingrowth 386 386
Use of Device Problem 347 347
Device Contaminated During Manufacture or Shipping 332 332
Biocompatibility 273 273
Device-Device Incompatibility 200 200
Packaging Problem 198 198
Break 188 188
Loss of or Failure to Bond 179 179
Loose or Intermittent Connection 140 140
Difficult to Remove 127 127
Unintended Movement 125 125
Positioning Failure 115 115
Patient Device Interaction Problem 103 103
Manufacturing, Packaging or Shipping Problem 98 98
Tear, Rip or Hole in Device Packaging 84 84
Separation Failure 83 83
Positioning Problem 83 83
Material Deformation 78 78
No Apparent Adverse Event 73 73
Off-Label Use 71 71
Failure to Osseointegrate 62 62
Migration or Expulsion of Device 60 60
Mechanical Problem 54 54
Device Appears to Trigger Rejection 53 53
Inadequacy of Device Shape and/or Size 51 51
Nonstandard Device 38 38
Patient-Device Incompatibility 32 32
Separation Problem 25 25
Difficult or Delayed Separation 24 24
Component Misassembled 24 24
Device Difficult to Setup or Prepare 24 24
Fitting Problem 24 24
Improper or Incorrect Procedure or Method 23 23
Material Integrity Problem 23 23
Material Twisted/Bent 22 22
Mechanical Jam 21 21
Defective Device 20 20
Material Fragmentation 19 19
Difficult to Advance 19 19
Physical Resistance/Sticking 19 19
Activation, Positioning or Separation Problem 18 18
Crack 18 18
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
Difficult to Open or Remove Packaging Material 10 10
Material Disintegration 10 10
Device Slipped 9 9
Device Damaged Prior to Use 9 9
Shipping Damage or Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Device Contamination with Chemical or Other Material 8 8
Scratched Material 7 7
Delivered as Unsterile Product 7 7
Labelling, Instructions for Use or Training Problem 6 6
Disconnection 6 6
Difficult or Delayed Positioning 6 6
Defective Component 6 6
Compatibility Problem 6 6
Illegible Information 6 6
Inaccurate Information 6 6
Deformation Due to Compressive Stress 5 5
Unsealed Device Packaging 5 5
Peeled/Delaminated 5 5
Material Frayed 4 4
Component Missing 4 4
Failure to Align 4 4
Problem with Sterilization 4 4
Wrong Label 4 4
Device Misassembled During Manufacturing /Shipping 3 3
Output Problem 3 3
Incomplete or Missing Packaging 3 3
Contamination 3 3
Device Reprocessing Problem 3 3
Failure to Disinfect 2 2
Entrapment of Device 2 2
Flaked 2 2
Pitted 2 2
Particulates 2 2
No Device Output 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8669 8669
No Code Available 5351 5351
Unspecified Infection 5020 5042
Joint Dislocation 4563 4578
Insufficient Information 2764 2764
Inadequate Osseointegration 2371 2371
Foreign Body Reaction 2192 2192
Injury 2022 2022
Metal Related Pathology 1784 1784
Joint Laxity 1711 1711
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1492 1492
No Clinical Signs, Symptoms or Conditions 1465 1465
Inflammation 1292 1292
Discomfort 1270 1270
Ambulation Difficulties 1257 1257
Bone Fracture(s) 1208 1208
Osteolysis 1189 1189
Tissue Damage 1155 1155
Test Result 937 937
Failure of Implant 934 934
Fall 899 899
Hypersensitivity/Allergic reaction 806 806
Loss of Range of Motion 756 756
Reaction 750 750
No Information 681 681
Swelling/ Edema 676 676
Unspecified Tissue Injury 664 664
Necrosis 585 585
Limited Mobility Of The Implanted Joint 567 567
Limb Fracture 553 553
No Known Impact Or Consequence To Patient 489 489
Scar Tissue 442 442
Adhesion(s) 383 383
Ossification 365 365
Hematoma 364 364
Distress 347 347
Muscle/Tendon Damage 311 311
Local Reaction 307 307
Synovitis 293 293
No Consequences Or Impact To Patient 280 280
Fatigue 277 277
Host-Tissue Reaction 269 269
Physical Asymmetry 269 269
Swelling 261 261
No Patient Involvement 256 256
Edema 238 238
Hemorrhage/Bleeding 204 204
Cyst(s) 195 195
Pulmonary Embolism 192 192
Nerve Damage 171 171
Fluid Discharge 165 165
Muscular Rigidity 162 162
Thrombosis/Thrombus 154 154
Osteopenia/ Osteoporosis 145 145
Deformity/ Disfigurement 136 136
Weakness 132 132
Anxiety 128 128
Wound Dehiscence 127 127
Impaired Healing 124 124
Cardiac Arrest 118 118
Numbness 107 107
Joint Disorder 106 106
Depression 106 106
Infarction, Cerebral 106 106
Hip Fracture 99 99
Not Applicable 91 91
Unequal Limb Length 80 80
Bacterial Infection 79 79
Foreign Body In Patient 74 74
Unspecified Musculoskeletal problem 73 73
Fever 69 69
Pocket Erosion 68 68
Post Operative Wound Infection 67 67
Erythema 66 66
Sepsis 64 64
Hypoesthesia 63 63
Blood Loss 60 60
Rash 60 60
Myocardial Infarction 58 58
Erosion 55 55
Thrombosis 54 54
Abscess 52 52
Seroma 48 48
Death 44 44
Patient Problem/Medical Problem 44 44
Fibrosis 43 43
Implant Pain 43 43
Stroke/CVA 41 41
Anemia 38 38
Memory Loss/Impairment 38 38
Pneumonia 35 35
Dizziness 35 35
Burning Sensation 33 33
Non-union Bone Fracture 29 29
Toxicity 28 28
Arrhythmia 28 28
Subluxation 27 27
Embolism/Embolus 25 25
Reaction to Medicinal Component of Device 24 24
Dyspnea 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 Apr-25-2024
16 Howmedica Osteonics Corp. II Feb-16-2022
17 Howmedica Osteonics Corp. II May-07-2020
18 Howmedica Osteonics Corp. II Nov-22-2019
19 Limacorporate S.p.A II Oct-21-2021
20 OMNIlife science Inc. II Oct-21-2019
21 OMNIlife science Inc. II Sep-05-2019
22 OmniLife Science II Nov-16-2021
23 Smith & Nephew, Inc. II Mar-20-2019
24 Waldemar Link GmbH & Co. KG (Mfg Site) II Sep-26-2023
25 Zimmer Biomet, Inc. II Oct-06-2020
26 Zimmer Biomet, Inc. II Nov-22-2019
27 Zimmer Biomet, Inc. II Nov-07-2019
28 Zimmer, Inc. II Mar-29-2023
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