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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 uncemented acetabular component)
Regulation Description Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
Product CodeKWA
Regulation Number 888.3330
Device Class 3

MDR Year MDR Reports MDR Events
2016 7868 7868
2017 6840 6840
2018 6383 6383
2019 7626 7626
2020 4545 4545
2021 971 971

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 10140 10140
Adverse Event Without Identified Device or Use Problem 7583 7583
Appropriate Term/Code Not Available 4608 4608
Naturally Worn 3218 3218
Device Dislodged or Dislocated 2790 2790
Loss of Osseointegration 1927 1927
Metal Shedding Debris 1314 1314
Material Erosion 1142 1142
Corroded 1116 1116
Fracture 766 766
Migration or Expulsion of Device 745 745
Noise, Audible 713 713
Malposition of Device 592 592
Device Contaminated During Manufacture or Shipping 542 542
Osseointegration Problem 541 541
Material Disintegration 506 506
Migration 444 444
Nonstandard Device 435 435
Loose or Intermittent Connection 408 408
Use of Device Problem 306 306
Biocompatibility 300 300
Break 297 297
Loss of or Failure to Bond 237 237
Unstable 228 228
Degraded 222 222
Disassembly 174 174
Loosening of Implant Not Related to Bone-Ingrowth 146 146
Difficult to Remove 134 134
Packaging Problem 133 133
Tear, Rip or Hole in Device Packaging 121 121
Separation Failure 98 98
Device Operates Differently Than Expected 88 88
Inadequacy of Device Shape and/or Size 86 86
Difficult to Insert 80 80
Device Packaging Compromised 73 73
Patient-Device Incompatibility 72 72
Device-Device Incompatibility 69 69
Compatibility Problem 66 66
Unintended Movement 66 66
Detachment of Device or Device Component 65 65
Failure to Osseointegrate 64 64
Mechanical Problem 59 59
Positioning Problem 54 54
Fitting Problem 43 43
Positioning Failure 42 42
Device Contamination with Chemical or Other Material 40 40
Device Slipped 39 39
Separation Problem 36 36
No Apparent Adverse Event 35 35
Failure To Adhere Or Bond 35 35
Material Deformation 27 27
Material Separation 24 24
Patient Device Interaction Problem 22 22
Material Integrity Problem 21 21
Delivered as Unsterile Product 19 19
Disconnection 17 17
Difficult To Position 17 17
Mechanical Jam 17 17
Material Twisted/Bent 16 16
Detachment Of Device Component 16 16
Scratched Material 16 16
Defective Device 15 15
Component Missing 15 15
Off-Label Use 14 14
Material Discolored 13 13
Manufacturing, Packaging or Shipping Problem 11 11
Unsealed Device Packaging 11 11
Problem with Sterilization 10 10
Crack 10 10
Material Fragmentation 10 10
Difficult or Delayed Separation 10 10
Device Markings/Labelling Problem 10 10
Improper or Incorrect Procedure or Method 9 9
Component or Accessory Incompatibility 9 9
Peeled/Delaminated 8 8
Entrapment of Device 7 7
Flaked 7 7
Connection Problem 6 6
Failure to Disconnect 6 6
Illegible Information 6 6
Shipping Damage or Problem 5 5
Contamination /Decontamination Problem 5 5
Improper Chemical Reaction 5 5
Defective Component 4 4
Collapse 4 4
Bent 4 4
Expiration Date Error 4 4
Therapeutic or Diagnostic Output Failure 3 3
Fluid Leak 3 3
Device Damaged Prior to Use 3 3
Misassembled 3 3
Difficult or Delayed Positioning 3 3
Biofilm coating in Device 3 3
Difficult to Advance 3 3
Physical Resistance/Sticking 3 3
Missing Information 2 2
Dull, Blunt 2 2
Product Quality Problem 2 2
Material Rupture 2 2
Incomplete or Missing Packaging 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15909 15910
No Code Available 12148 12150
No Information 4654 4654
Foreign Body Reaction 4285 4285
Discomfort 3150 3150
Test Result 3143 3143
Unspecified Infection 2879 2880
Tissue Damage 2798 2798
Reaction 2463 2463
Osteolysis 2357 2357
Host-Tissue Reaction 2322 2322
Injury 2252 2252
Joint Dislocation 2058 2058
Limited Mobility Of The Implanted Joint 1895 1895
Not Applicable 1593 1593
Inadequate Osseointegration 1567 1568
Inflammation 1500 1500
Hypersensitivity/Allergic reaction 1191 1191
Bone Fracture(s) 1126 1126
Loss of Range of Motion 971 971
Ambulation Difficulties 788 788
Necrosis 699 699
Weakness 658 658
Edema 649 649
Swelling 628 628
No Known Impact Or Consequence To Patient 571 571
Distress 556 556
No Consequences Or Impact To Patient 526 526
No Patient Involvement 514 514
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 443 443
Synovitis 425 425
Cyst(s) 415 415
Adhesion(s) 382 382
Anxiety 280 280
Local Reaction 270 270
Toxicity 270 270
Muscular Rigidity 233 233
Failure of Implant 227 227
Fall 216 216
Scar Tissue 216 216
Hematoma 214 214
Ossification 211 211
Fatigue 200 200
Fluid Discharge 185 185
Thrombosis 176 176
Joint Disorder 171 171
Deformity/ Disfigurement 167 167
Hip Fracture 148 148
Blood Loss 140 140
Pulmonary Embolism 138 138
Metal Related Pathology 133 133
Insufficient Information 131 131
Death 107 107
Hemorrhage/Bleeding 103 103
Depression 95 95
Erosion 93 93
Fibrosis 88 88
Swelling/ Edema 86 86
Scarring 84 84
Hypoesthesia 80 80
Nerve Damage 78 78
Joint Swelling 76 76
Wound Dehiscence 76 76
No Clinical Signs, Symptoms or Conditions 73 73
Osteopenia/ Osteoporosis 71 71
Pocket Erosion 66 66
Cardiac Arrest 65 65
Unspecified Tissue Injury 61 61
Infarction, Cerebral 60 60
Irritation 59 59
Fever 56 56
Sepsis 55 55
Myocardial Infarction 54 54
Headache 52 52
Rash 51 51
Abscess 46 46
Calcium Deposits/Calcification 45 45
Skin Irritation 45 45
Joint Laxity 45 45
Impaired Healing 45 45
Numbness 39 39
Foreign Body In Patient 36 36
Stroke/CVA 36 36
Complaint, Ill-Defined 35 35
Memory Loss/Impairment 35 35
Hearing Impairment 35 35
Physical Asymmetry 32 32
Nausea 31 31
Tinnitus 31 31
Post Operative Wound Infection 30 30
Renal Failure 30 30
Burning Sensation 29 29
Bacterial Infection 28 28
Anemia 28 28
Heart Failure 25 25
Patient Problem/Medical Problem 24 24
Itching Sensation 24 24
Neuropathy 23 23
Muscle Spasm(s) 23 23
Sleep Dysfunction 22 22

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Jan-07-2021
2 Encore Medical, Lp II Feb-11-2017
3 Zimmer Biomet, Inc. II Nov-07-2019
4 Zimmer Biomet, Inc. II Dec-19-2018
5 Zimmer Biomet, Inc. II Aug-14-2018
6 Zimmer Biomet, Inc. II Dec-29-2017
7 Zimmer Biomet, Inc. II Feb-22-2016
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