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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 7863 7863
2017 6839 6839
2018 6377 6377
2019 7626 7626
2020 4544 4544
2021 254 254

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 10114 10114
Adverse Event Without Identified Device or Use Problem 7197 7197
Appropriate Term/Code Not Available 4591 4591
Naturally Worn 3127 3127
Device Dislodged or Dislocated 2735 2735
Loss of Osseointegration 1918 1918
Metal Shedding Debris 1314 1314
Material Erosion 1111 1111
Corroded 1096 1096
Migration or Expulsion of Device 744 744
Fracture 737 737
Noise, Audible 689 689
Malposition of Device 590 590
Device Contaminated During Manufacture or Shipping 539 539
Osseointegration Problem 505 505
Material Disintegration 501 501
Nonstandard Device 436 436
Migration 431 431
Loose or Intermittent Connection 407 407
Use of Device Problem 300 300
Biocompatibility 293 293
Break 292 292
Loss of or Failure to Bond 236 236
Unstable 225 225
Degraded 213 213
Disassembly 174 174
Difficult to Remove 133 133
Loosening of Implant Not Related to Bone-Ingrowth 132 132
Packaging Problem 115 115
Tear, Rip or Hole in Device Packaging 113 113
Separation Failure 94 94
Device Operates Differently Than Expected 88 88
Inadequacy of Device Shape and/or Size 81 81
Device Packaging Compromised 73 73
Difficult to Insert 71 71
Compatibility Problem 66 66
Unintended Movement 65 65
Failure to Osseointegrate 64 64
Device-Device Incompatibility 63 63
Detachment of Device or Device Component 61 61
Patient-Device Incompatibility 60 60
Mechanical Problem 59 59
Positioning Problem 53 53
Fitting Problem 43 43
Device Contamination with Chemical or Other Material 40 40
Positioning Failure 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 23 23
Material Integrity Problem 20 20
Delivered as Unsterile Product 19 19
Disconnection 17 17
Difficult To Position 17 17
Mechanical Jam 16 16
Detachment Of Device Component 16 16
Scratched Material 16 16
Material Twisted/Bent 15 15
Defective Device 15 15
Component Missing 15 15
Off-Label Use 14 14
Material Discolored 13 13
Difficult or Delayed Separation 12 12
Patient Device Interaction Problem 10 10
Problem with Sterilization 10 10
Crack 10 10
Device Markings/Labelling Problem 10 10
Improper or Incorrect Procedure or Method 9 9
Material Fragmentation 9 9
Component or Accessory Incompatibility 9 9
Unsealed Device Packaging 7 7
Peeled/Delaminated 7 7
Entrapment of Device 7 7
Connection Problem 6 6
Failure to Disconnect 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Improper Chemical Reaction 5 5
Flaked 5 5
Shipping Damage or Problem 5 5
Cup 4 4
Bent 4 4
Collapse 4 4
Expiration Date Error 4 4
Defective Component 4 4
Physical Resistance/Sticking 3 3
Biofilm coating in Device 3 3
Device Damaged Prior to Use 3 3
Fluid Leak 3 3
Illegible Information 3 3
Inaccurate Information 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Abrasion From Instrument Or Another Object 2 2
Component Incompatible 2 2
Screw 2 2
Device Damaged by Another Device 2 2
Physical Property Issue 2 2
Computer Operating System Problem 2 2
Device Or Device Fragments Location Unknown 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15577 15578
No Code Available 12139 12141
No Information 4656 4656
Foreign Body Reaction 4100 4100
Test Result 3143 3143
Discomfort 3112 3112
Unspecified Infection 2866 2867
Tissue Damage 2800 2800
Reaction 2461 2461
Host-Tissue Reaction 2322 2322
Osteolysis 2277 2277
Injury 2246 2246
Joint Dislocation 2021 2021
Limited Mobility Of The Implanted Joint 1888 1888
Not Applicable 1593 1593
Inadequate Osseointegration 1529 1530
Inflammation 1481 1481
Hypersensitivity/Allergic reaction 1124 1124
Bone Fracture(s) 1113 1113
Loss of Range of Motion 936 936
Ambulation Difficulties 737 737
Necrosis 680 680
Weakness 658 658
Edema 649 649
Swelling 625 625
No Known Impact Or Consequence To Patient 567 567
No Consequences Or Impact To Patient 525 525
Distress 525 525
No Patient Involvement 512 512
Cyst(s) 401 401
Synovitis 399 399
Adhesion(s) 347 347
Anxiety 277 277
Toxicity 270 270
Local Reaction 253 253
Muscular Rigidity 230 230
Hematoma 211 211
Scar Tissue 209 209
Fall 206 206
Ossification 199 199
Failure of Implant 198 198
Fatigue 187 187
Fluid Discharge 183 183
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 179 179
Thrombosis 176 176
Joint Disorder 171 171
Deformity/ Disfigurement 166 166
Hip Fracture 145 145
Blood Loss 140 140
Pulmonary Embolism 138 138
Death 107 107
Hemorrhage/Bleeding 99 99
Depression 94 94
Erosion 92 92
Fibrosis 87 87
Scarring 84 84
Hypoesthesia 80 80
Wound Dehiscence 76 76
Nerve Damage 76 76
Joint Swelling 76 76
Osteopenia/ Osteoporosis 68 68
Pocket Erosion 66 66
Cardiac Arrest 65 65
Infarction, Cerebral 60 60
Irritation 59 59
Sepsis 56 56
Fever 56 56
Insufficient Information 54 54
Myocardial Infarction 54 54
Headache 51 51
Rash 47 47
Abscess 46 46
Skin Irritation 45 45
Impaired Healing 40 40
Calcium Deposits/Calcification 39 39
Numbness 37 37
Hearing Impairment 35 35
Memory Loss/Impairment 35 35
Complaint, Ill-Defined 35 35
Foreign Body In Patient 34 34
Metal Related Pathology 34 34
Stroke/CVA 33 33
Nausea 31 31
Tinnitus 30 30
Post Operative Wound Infection 30 30
Renal Failure 30 30
Anemia 27 27
Burning Sensation 27 27
Unspecified Tissue Injury 26 26
Heart Failure 25 25
Swelling/ Edema 23 23
Patient Problem/Medical Problem 23 23
Bacterial Infection 23 23
Neuropathy 23 23
Muscle Spasm(s) 23 23
Sleep Dysfunction 22 22
Malaise 22 22
Itching Sensation 22 22
Purulent Discharge 20 20
Cognitive Changes 20 20

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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