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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 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 5983 5983
2022 5224 5224
2023 5377 5414
2024 1854 1854

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12605 12627
Device Dislodged or Dislocated 5539 5554
Insufficient Information 2184 2184
Naturally Worn 1626 1626
Fracture 1590 1590
Osseointegration Problem 1338 1338
Loss of Osseointegration 1238 1238
Material Erosion 1085 1085
Corroded 878 878
Degraded 772 772
Appropriate Term/Code Not Available 692 692
Difficult to Insert 622 622
Migration 607 607
Detachment of Device or Device Component 464 464
Unstable 453 453
Malposition of Device 410 410
Noise, Audible 393 393
Loosening of Implant Not Related to Bone-Ingrowth 370 370
Use of Device Problem 340 340
Device Contaminated During Manufacture or Shipping 331 331
Biocompatibility 272 272
Packaging Problem 193 193
Break 188 188
Device-Device Incompatibility 186 186
Loss of or Failure to Bond 174 174
Loose or Intermittent Connection 140 140
Difficult to Remove 125 125
Unintended Movement 123 123
Positioning Failure 114 114
Patient Device Interaction Problem 102 102
Manufacturing, Packaging or Shipping Problem 90 90
Positioning Problem 83 83
Tear, Rip or Hole in Device Packaging 82 82
Separation Failure 81 81
Material Deformation 76 76
Off-Label Use 70 70
No Apparent Adverse Event 67 67
Failure to Osseointegrate 59 59
Migration or Expulsion of Device 58 58
Mechanical Problem 53 53
Device Appears to Trigger Rejection 52 52
Inadequacy of Device Shape and/or Size 51 51
Nonstandard Device 38 38
Patient-Device Incompatibility 32 32
Difficult or Delayed Separation 24 24
Component Misassembled 24 24
Fitting Problem 24 24
Improper or Incorrect Procedure or Method 23 23
Device Difficult to Setup or Prepare 23 23
Separation Problem 22 22
Material Integrity Problem 22 22
Material Twisted/Bent 21 21
Mechanical Jam 21 21
Defective Device 20 20
Physical Resistance/Sticking 19 19
Difficult to Advance 18 18
Activation, Positioning or Separation Problem 18 18
Material Fragmentation 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
Material Disintegration 10 10
Device Slipped 9 9
Device Damaged Prior to Use 9 9
Difficult to Open or Remove Packaging Material 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Contamination with Chemical or Other Material 8 8
Shipping Damage or Problem 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 8457 8457
No Code Available 5350 5350
Unspecified Infection 4822 4844
Joint Dislocation 4360 4375
Insufficient Information 2600 2600
Inadequate Osseointegration 2318 2318
Foreign Body Reaction 2121 2121
Injury 2020 2020
Metal Related Pathology 1668 1668
Joint Laxity 1633 1633
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1490 1490
No Clinical Signs, Symptoms or Conditions 1394 1394
Inflammation 1275 1275
Discomfort 1253 1253
Ambulation Difficulties 1212 1212
Bone Fracture(s) 1173 1173
Osteolysis 1159 1159
Tissue Damage 1155 1155
Test Result 936 936
Failure of Implant 903 903
Fall 875 875
Hypersensitivity/Allergic reaction 791 791
Reaction 748 748
Loss of Range of Motion 742 742
No Information 681 681
Swelling/ Edema 661 661
Unspecified Tissue Injury 635 635
Necrosis 576 576
Limited Mobility Of The Implanted Joint 567 567
Limb Fracture 521 521
No Known Impact Or Consequence To Patient 489 489
Scar Tissue 437 437
Adhesion(s) 380 380
Ossification 348 348
Hematoma 343 343
Distress 341 341
Local Reaction 307 307
Muscle/Tendon Damage 305 305
Synovitis 287 287
No Consequences Or Impact To Patient 280 280
Fatigue 272 272
Host-Tissue Reaction 269 269
Swelling 261 261
No Patient Involvement 256 256
Physical Asymmetry 253 253
Edema 238 238
Hemorrhage/Bleeding 197 197
Cyst(s) 195 195
Pulmonary Embolism 189 189
Muscular Rigidity 160 160
Nerve Damage 158 158
Fluid Discharge 152 152
Thrombosis/Thrombus 138 138
Osteopenia/ Osteoporosis 136 136
Deformity/ Disfigurement 135 135
Weakness 132 132
Anxiety 128 128
Cardiac Arrest 118 118
Wound Dehiscence 114 114
Impaired Healing 113 113
Depression 106 106
Joint Disorder 106 106
Infarction, Cerebral 106 106
Numbness 100 100
Hip Fracture 96 96
Not Applicable 91 91
Bacterial Infection 78 78
Unequal Limb Length 74 74
Foreign Body In Patient 72 72
Unspecified Musculoskeletal problem 70 70
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
Myocardial Infarction 58 58
Erosion 55 55
Thrombosis 54 54
Abscess 50 50
Death 44 44
Patient Problem/Medical Problem 44 44
Fibrosis 43 43
Implant Pain 42 42
Seroma 42 42
Stroke/CVA 41 41
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 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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