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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)
Product CodeKWA
Regulation Number 888.3330
Device Class 3

MDR Year MDR Reports MDR Events
2017 6843 6843
2018 6394 6394
2019 7635 7635
2020 4544 4544
2021 2078 2078
2022 1182 1182

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8364 8364
Insufficient Information 6748 6748
Naturally Worn 2788 2788
Device Dislodged or Dislocated 2575 2575
Appropriate Term/Code Not Available 2491 2491
Loss of Osseointegration 1492 1492
Material Erosion 925 925
Corroded 886 886
Fracture 750 750
Metal Shedding Debris 668 668
Osseointegration Problem 617 617
Device Contaminated During Manufacture or Shipping 563 563
Migration or Expulsion of Device 517 517
Migration 501 501
Noise, Audible 488 488
Malposition of Device 462 462
Nonstandard Device 411 411
Material Disintegration 404 404
Use of Device Problem 328 328
Biocompatibility 311 311
Loose or Intermittent Connection 261 261
Degraded 234 234
Loss of or Failure to Bond 223 223
Unstable 215 215
Loosening of Implant Not Related to Bone-Ingrowth 201 201
Break 195 195
Packaging Problem 174 174
Tear, Rip or Hole in Device Packaging 158 158
Disassembly 123 123
Difficult to Remove 108 108
Difficult to Insert 107 107
Patient Device Interaction Problem 87 87
Separation Failure 83 83
Detachment of Device or Device Component 80 80
Device-Device Incompatibility 74 74
Inadequacy of Device Shape and/or Size 72 72
Unintended Movement 71 71
Device Packaging Compromised 68 68
Failure to Osseointegrate 59 59
Patient-Device Incompatibility 54 54
Positioning Failure 46 46
No Apparent Adverse Event 39 39
Device Contamination with Chemical or Other Material 38 38
Fitting Problem 37 37
Separation Problem 36 36
Mechanical Problem 31 31
Positioning Problem 29 29
Material Deformation 29 29
Manufacturing, Packaging or Shipping Problem 28 28
Material Integrity Problem 27 27
Material Separation 24 24
Off-Label Use 24 24
Delivered as Unsterile Product 19 19
Failure To Adhere Or Bond 19 19
Mechanical Jam 19 19
Material Twisted/Bent 17 17
Disconnection 17 17
Component Missing 16 16
Compatibility Problem 16 16
Defective Device 15 15
Scratched Material 15 15
Difficult To Position 14 14
Device Operates Differently Than Expected 13 13
Unsealed Device Packaging 11 11
Problem with Sterilization 10 10
Material Fragmentation 10 10
Difficult or Delayed Separation 10 10
Flaked 9 9
Material Discolored 9 9
Device Markings/Labelling Problem 8 8
Crack 7 7
Device Slipped 7 7
Peeled/Delaminated 7 7
Shipping Damage or Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Detachment Of Device Component 6 6
Contamination /Decontamination Problem 6 6
Illegible Information 6 6
Output Problem 6 6
Physical Resistance/Sticking 5 5
Connection Problem 5 5
Difficult to Open or Remove Packaging Material 5 5
Difficult or Delayed Positioning 5 5
Entrapment of Device 5 5
Misassembled 4 4
Difficult to Advance 4 4
Expiration Date Error 4 4
Therapeutic or Diagnostic Output Failure 4 4
Missing Information 3 3
Failure to Disconnect 3 3
Bent 3 3
Biofilm coating in Device 3 3
Collapse 3 3
Device Damaged Prior to Use 3 3
Defective Component 3 3
Incomplete or Missing Packaging 3 3
Failure to Align 3 3
Dull, Blunt 2 2
Material Rupture 2 2
Activation, Positioning or SeparationProblem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 12529 12530
No Code Available 10575 10577
Foreign Body Reaction 3702 3702
Test Result 3086 3086
No Information 3019 3019
Unspecified Infection 2744 2745
Tissue Damage 2504 2504
Discomfort 2313 2313
Joint Dislocation 2060 2060
Osteolysis 2044 2044
Injury 2025 2025
Reaction 1785 1785
Inadequate Osseointegration 1625 1626
Limited Mobility Of The Implanted Joint 1565 1565
Not Applicable 1502 1502
Host-Tissue Reaction 1354 1354
Hypersensitivity/Allergic reaction 1254 1254
Inflammation 1207 1207
Bone Fracture(s) 1020 1020
Loss of Range of Motion 920 920
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 882 882
Ambulation Difficulties 770 770
Necrosis 686 686
Distress 674 674
Edema 627 627
Metal Related Pathology 570 570
Weakness 557 557
No Patient Involvement 511 511
No Consequences Or Impact To Patient 504 504
No Known Impact Or Consequence To Patient 501 501
Swelling 500 500
Adhesion(s) 428 428
Cyst(s) 397 397
Failure of Implant 365 365
Insufficient Information 353 353
Synovitis 341 341
No Clinical Signs, Symptoms or Conditions 319 319
Local Reaction 278 278
Swelling/ Edema 273 273
Anxiety 272 272
Scar Tissue 271 271
Deformity/ Disfigurement 232 232
Fatigue 221 221
Hematoma 215 215
Fall 215 215
Muscular Rigidity 214 214
Ossification 204 204
Unspecified Tissue Injury 194 194
Thrombosis 175 175
Joint Laxity 149 149
Joint Disorder 147 147
Fluid Discharge 145 145
Pulmonary Embolism 143 143
Blood Loss 134 134
Hemorrhage/Bleeding 119 119
Hip Fracture 114 114
Erosion 94 94
Osteopenia/ Osteoporosis 93 93
Depression 91 91
Pocket Erosion 87 87
Fibrosis 83 83
Toxicity 82 82
Nerve Damage 79 79
Death 77 77
Wound Dehiscence 75 75
Scarring 73 73
Hypoesthesia 69 69
Cardiac Arrest 66 66
Physical Asymmetry 61 61
Infarction, Cerebral 57 57
Sepsis 55 55
Impaired Healing 55 55
Myocardial Infarction 54 54
Rash 54 54
Fever 54 54
Abscess 54 54
Headache 45 45
Muscle/Tendon Damage 44 44
Calcium Deposits/Calcification 43 43
Post Operative Wound Infection 42 42
Memory Loss/Impairment 40 40
Irritation 39 39
Stroke/CVA 39 39
Numbness 39 39
Foreign Body In Patient 37 37
Skin Irritation 35 35
Renal Failure 35 35
Hearing Impairment 33 33
Bacterial Infection 33 33
Anemia 31 31
Tinnitus 30 30
Burning Sensation 29 29
Limb Fracture 28 28
Joint Swelling 27 27
Nausea 24 24
Neuropathy 24 24
Dyspnea 24 24
Itching Sensation 23 23
Heart Failure 23 23
Muscle Spasm(s) 22 22

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Aug-12-2021
2 DePuy Orthopaedics, Inc. II Jan-07-2021
3 Encore Medical, Lp II Feb-11-2017
4 Zimmer Biomet, Inc. II Nov-07-2019
5 Zimmer Biomet, Inc. II Dec-19-2018
6 Zimmer Biomet, Inc. II Aug-14-2018
7 Zimmer Biomet, Inc. II Dec-29-2017
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