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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
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 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 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 2
MICROPORT ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ONKOS SURGICAL, INC.
  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 7
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
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
2018 5902 5902
2019 7093 7093
2020 5418 5418
2021 6010 6010
2022 5271 5271
2023 806 806

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10438 10438
Device Dislodged or Dislocated 5175 5175
Insufficient Information 3741 3741
Fracture 1520 1520
Loss of Osseointegration 1512 1512
Naturally Worn 1477 1477
Osseointegration Problem 1254 1254
Appropriate Term/Code Not Available 1069 1069
Corroded 1032 1032
Material Erosion 1004 1004
Degraded 700 700
Difficult to Insert 541 541
Migration 535 535
Malposition of Device 489 489
Unstable 481 481
Detachment of Device or Device Component 370 370
Noise, Audible 368 368
Biocompatibility 357 357
Device Contaminated During Manufacture or Shipping 340 340
Loose or Intermittent Connection 305 305
Use of Device Problem 297 297
Break 262 262
Loosening of Implant Not Related to Bone-Ingrowth 242 242
Migration or Expulsion of Device 210 210
Packaging Problem 207 207
Loss of or Failure to Bond 180 180
Material Deformation 151 151
Device-Device Incompatibility 145 145
Difficult to Remove 132 132
Unintended Movement 120 120
Positioning Problem 95 95
Positioning Failure 92 92
Failure to Osseointegrate 84 84
Separation Failure 83 83
Tear, Rip or Hole in Device Packaging 79 79
Disassembly 78 78
Patient Device Interaction Problem 68 68
Inadequacy of Device Shape and/or Size 66 66
Mechanical Problem 66 66
Metal Shedding Debris 52 52
Off-Label Use 50 50
Manufacturing, Packaging or Shipping Problem 49 49
Separation Problem 48 48
Fitting Problem 45 45
No Apparent Adverse Event 44 44
Nonstandard Device 40 40
Material Disintegration 40 40
Patient-Device Incompatibility 35 35
Device Contamination with Chemical or Other Material 30 30
Crack 28 28
Device Appears to Trigger Rejection 28 28
Device Difficult to Setup or Prepare 26 26
Device Operates Differently Than Expected 26 26
Physical Resistance/Sticking 25 25
Material Discolored 24 24
Material Fragmentation 23 23
Device Packaging Compromised 23 23
Difficult or Delayed Separation 23 23
Component Misassembled 23 23
Mechanical Jam 22 22
Material Twisted/Bent 22 22
Material Separation 22 22
Improper or Incorrect Procedure or Method 21 21
Defective Device 20 20
Scratched Material 19 19
Device Damaged by Another Device 18 18
Contamination /Decontamination Problem 18 18
Connection Problem 18 18
Detachment Of Device Component 18 18
Device Slipped 16 16
Device Markings/Labelling Problem 16 16
Activation, Positioning or Separation Problem 16 16
Material Integrity Problem 16 16
Disconnection 13 13
Difficult to Open or Remove Packaging Material 12 12
Delamination 12 12
Difficult to Advance 11 11
Failure To Adhere Or Bond 11 11
Difficult or Delayed Positioning 10 10
Difficult To Position 10 10
Shipping Damage or Problem 9 9
Delivered as Unsterile Product 8 8
Compatibility Problem 8 8
Material Distortion 8 8
Therapeutic or Diagnostic Output Failure 8 8
Dull, Blunt 7 7
Contamination 7 7
Labelling, Instructions for Use or Training Problem 7 7
Device Damaged Prior to Use 6 6
Inaccurate Information 6 6
Illegible Information 5 5
Problem with Sterilization 5 5
Flaked 5 5
Component Missing 5 5
Deformation Due to Compressive Stress 5 5
Failure to Align 4 4
Unsealed Device Packaging 4 4
Material Split, Cut or Torn 4 4
Particulates 3 3
Peeled/Delaminated 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8983 8983
No Code Available 6354 6354
Unspecified Infection 4652 4652
Joint Dislocation 4143 4143
Injury 3204 3204
Inadequate Osseointegration 2535 2535
Foreign Body Reaction 1869 1869
Inflammation 1672 1672
Insufficient Information 1653 1653
Discomfort 1650 1650
Tissue Damage 1617 1617
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1487 1487
Test Result 1420 1420
Bone Fracture(s) 1222 1222
Reaction 1191 1191
Ambulation Difficulties 1089 1089
Osteolysis 1064 1064
Joint Laxity 1050 1050
Metal Related Pathology 1048 1048
No Information 1013 1013
No Clinical Signs, Symptoms or Conditions 933 933
Not Applicable 914 914
Limited Mobility Of The Implanted Joint 854 854
Fall 787 787
Loss of Range of Motion 775 775
Hypersensitivity/Allergic reaction 720 720
Failure of Implant 672 672
No Known Impact Or Consequence To Patient 653 653
Necrosis 587 587
No Consequences Or Impact To Patient 508 508
Host-Tissue Reaction 447 447
Swelling/ Edema 438 438
Unspecified Tissue Injury 420 420
Swelling 393 393
Scar Tissue 381 381
Local Reaction 355 355
Distress 349 349
Hematoma 335 335
Adhesion(s) 320 320
Limb Fracture 319 319
No Patient Involvement 311 311
Ossification 292 292
Edema 288 288
Synovitis 250 250
Weakness 245 245
Fatigue 210 210
Pulmonary Embolism 195 195
Cyst(s) 188 188
Muscle/Tendon Damage 177 177
Hemorrhage/Bleeding 176 176
Joint Disorder 169 169
Physical Asymmetry 167 167
Infarction, Cerebral 142 142
Cardiac Arrest 140 140
Deformity/ Disfigurement 136 136
Anxiety 131 131
Nerve Damage 131 131
Fluid Discharge 126 126
Hip Fracture 118 118
Muscular Rigidity 112 112
Blood Loss 107 107
Thrombosis/Thrombus 101 101
Impaired Healing 100 100
Osteopenia/ Osteoporosis 98 98
Depression 85 85
Hypoesthesia 83 83
Wound Dehiscence 80 80
Bacterial Infection 78 78
Numbness 76 76
Foreign Body In Patient 71 71
Erosion 68 68
Sepsis 65 65
Rash 65 65
Post Operative Wound Infection 64 64
Fever 62 62
Myocardial Infarction 61 61
Thrombosis 61 61
Death 60 60
Pocket Erosion 51 51
Patient Problem/Medical Problem 49 49
Abscess 48 48
Unspecified Musculoskeletal problem 45 45
Burning Sensation 44 44
Stroke/CVA 41 41
Unequal Limb Length 38 38
Erythema 37 37
Toxicity 36 36
Dizziness 35 35
Memory Loss/Impairment 34 34
Headache 33 33
Anemia 33 33
Fibrosis 32 32
Pneumonia 28 28
Neuropathy 27 27
Scarring 27 27
Tinnitus 25 25
Calcium Deposits/Calcification 25 25
Arrhythmia 24 24
Seroma 23 23
Reaction to Medicinal Component of Device 23 23

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-21-2022
8 Encore Medical, LP II Oct-20-2020
9 Encore Medical, LP II May-08-2020
10 Encore Medical, LP II Apr-10-2020
11 Exactech, Inc. II Sep-09-2022
12 Exactech, Inc. II Jul-22-2021
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
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