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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 3
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 S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC ADVANCED ENERGY
  SUBSTANTIALLY EQUIVALENT 1
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
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 5914 5914
2019 7103 7103
2020 5420 5420
2021 5983 5983
2022 5221 5221
2023 3597 3634

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 11783 11805
Device Dislodged or Dislocated 5735 5750
Insufficient Information 3814 3814
Fracture 1647 1647
Naturally Worn 1646 1646
Loss of Osseointegration 1525 1525
Osseointegration Problem 1356 1356
Material Erosion 1091 1091
Appropriate Term/Code Not Available 1079 1079
Corroded 1069 1069
Degraded 790 790
Difficult to Insert 583 583
Migration 582 582
Unstable 513 513
Malposition of Device 509 509
Detachment of Device or Device Component 435 435
Noise, Audible 415 415
Biocompatibility 356 356
Device Contaminated During Manufacture or Shipping 344 344
Use of Device Problem 329 329
Loose or Intermittent Connection 305 305
Loosening of Implant Not Related to Bone-Ingrowth 281 281
Break 266 266
Packaging Problem 219 219
Migration or Expulsion of Device 215 215
Loss of or Failure to Bond 188 188
Device-Device Incompatibility 166 166
Material Deformation 162 162
Difficult to Remove 145 145
Unintended Movement 129 129
Positioning Problem 105 105
Positioning Failure 102 102
Patient Device Interaction Problem 91 91
Failure to Osseointegrate 90 90
Separation Failure 84 84
Tear, Rip or Hole in Device Packaging 81 81
Disassembly 78 78
Manufacturing, Packaging or Shipping Problem 75 75
Mechanical Problem 73 73
Inadequacy of Device Shape and/or Size 66 66
No Apparent Adverse Event 63 63
Off-Label Use 61 61
Metal Shedding Debris 53 53
Separation Problem 50 50
Fitting Problem 45 45
Device Appears to Trigger Rejection 41 41
Material Disintegration 41 41
Nonstandard Device 40 40
Patient-Device Incompatibility 35 35
Device Contamination with Chemical or Other Material 30 30
Crack 27 27
Device Difficult to Setup or Prepare 26 26
Device Operates Differently Than Expected 26 26
Physical Resistance/Sticking 26 26
Component Misassembled 24 24
Difficult or Delayed Separation 24 24
Material Discolored 24 24
Material Fragmentation 23 23
Improper or Incorrect Procedure or Method 23 23
Device Packaging Compromised 23 23
Material Twisted/Bent 23 23
Mechanical Jam 22 22
Material Separation 22 22
Defective Device 21 21
Material Integrity Problem 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 Markings/Labelling Problem 17 17
Activation, Positioning or Separation Problem 16 16
Difficult to Advance 16 16
Device Slipped 16 16
Disconnection 13 13
Difficult to Open or Remove Packaging Material 12 12
Delamination 12 12
Failure To Adhere Or Bond 11 11
Difficult or Delayed Positioning 10 10
Difficult To Position 10 10
Shipping Damage or Problem 9 9
Device Damaged Prior to Use 9 9
Delivered as Unsterile Product 8 8
Material Distortion 8 8
Compatibility Problem 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
Deformation Due to Compressive Stress 6 6
Illegible Information 6 6
Inaccurate Information 6 6
Component Missing 5 5
Flaked 5 5
Unsealed Device Packaging 5 5
Problem with Sterilization 5 5
Defective Component 4 4
Peeled/Delaminated 4 4
Failure to Align 4 4
Material Protrusion/Extrusion 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 9669 9669
No Code Available 6359 6359
Unspecified Infection 5153 5175
Joint Dislocation 4630 4645
Injury 3214 3214
Inadequate Osseointegration 2650 2650
Foreign Body Reaction 2093 2093
Insufficient Information 2025 2025
Discomfort 1751 1751
Inflammation 1750 1750
Tissue Damage 1621 1621
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1496 1496
Test Result 1421 1421
Metal Related Pathology 1379 1379
Bone Fracture(s) 1318 1318
Joint Laxity 1304 1304
Ambulation Difficulties 1260 1260
Reaction 1198 1198
Osteolysis 1191 1191
No Clinical Signs, Symptoms or Conditions 1132 1132
No Information 1012 1012
Not Applicable 919 919
Fall 885 885
Loss of Range of Motion 860 860
Limited Mobility Of The Implanted Joint 854 854
Failure of Implant 838 838
Hypersensitivity/Allergic reaction 822 822
No Known Impact Or Consequence To Patient 653 653
Necrosis 641 641
Unspecified Tissue Injury 573 573
Swelling/ Edema 571 571
No Consequences Or Impact To Patient 508 508
Host-Tissue Reaction 449 449
Scar Tissue 431 431
Distress 418 418
Swelling 392 392
Adhesion(s) 387 387
Limb Fracture 381 381
Hematoma 373 373
Local Reaction 357 357
Ossification 347 347
No Patient Involvement 311 311
Edema 289 289
Synovitis 284 284
Fatigue 269 269
Weakness 247 247
Muscle/Tendon Damage 244 244
Cyst(s) 214 214
Physical Asymmetry 209 209
Pulmonary Embolism 195 195
Hemorrhage/Bleeding 192 192
Joint Disorder 171 171
Anxiety 149 149
Deformity/ Disfigurement 148 148
Nerve Damage 146 146
Muscular Rigidity 146 146
Infarction, Cerebral 142 142
Cardiac Arrest 141 141
Fluid Discharge 138 138
Osteopenia/ Osteoporosis 123 123
Hip Fracture 119 119
Thrombosis/Thrombus 114 114
Wound Dehiscence 108 108
Depression 107 107
Blood Loss 107 107
Impaired Healing 104 104
Numbness 97 97
Hypoesthesia 83 83
Foreign Body In Patient 82 82
Bacterial Infection 79 79
Fever 77 77
Erosion 68 68
Rash 66 66
Pocket Erosion 65 65
Sepsis 65 65
Myocardial Infarction 65 65
Post Operative Wound Infection 64 64
Unspecified Musculoskeletal problem 63 63
Thrombosis 61 61
Death 60 60
Abscess 56 56
Fibrosis 52 52
Unequal Limb Length 51 51
Patient Problem/Medical Problem 49 49
Erythema 48 48
Burning Sensation 45 45
Memory Loss/Impairment 41 41
Stroke/CVA 41 41
Anemia 38 38
Dizziness 38 38
Seroma 37 37
Toxicity 36 36
Headache 32 32
Pneumonia 31 31
Arrhythmia 29 29
Neuropathy 28 28
Scarring 27 27
Cellulitis 27 27
Calcium Deposits/Calcification 25 25
Tinnitus 25 25

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 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 Biomet, Inc. II Jul-05-2018
28 Zimmer Biomet, Inc. II Apr-27-2018
29 Zimmer Biomet, Inc. II Mar-14-2018
30 Zimmer Biomet, Inc. II Mar-14-2018
31 Zimmer Biomet, Inc. II Mar-09-2018
32 Zimmer Biomet, Inc. II Feb-26-2018
33 Zimmer Biomet, Inc. II Jan-04-2018
34 Zimmer, Inc. II Mar-29-2023
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