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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 7869 7869
2017 6840 6840
2018 6386 6386
2019 7631 7631
2020 4543 4543
2021 1440 1440

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 10169 10169
Adverse Event Without Identified Device or Use Problem 7858 7858
Appropriate Term/Code Not Available 4622 4622
Naturally Worn 3261 3261
Device Dislodged or Dislocated 2822 2822
Loss of Osseointegration 1930 1930
Metal Shedding Debris 1314 1314
Material Erosion 1158 1158
Corroded 1133 1133
Fracture 785 785
Migration or Expulsion of Device 745 745
Noise, Audible 726 726
Malposition of Device 593 593
Osseointegration Problem 562 562
Device Contaminated During Manufacture or Shipping 544 544
Material Disintegration 508 508
Migration 453 453
Nonstandard Device 436 436
Loose or Intermittent Connection 408 408
Use of Device Problem 314 314
Biocompatibility 307 307
Break 297 297
Loss of or Failure to Bond 238 238
Unstable 234 234
Degraded 230 230
Disassembly 174 174
Packaging Problem 154 154
Loosening of Implant Not Related to Bone-Ingrowth 149 149
Difficult to Remove 134 134
Tear, Rip or Hole in Device Packaging 121 121
Separation Failure 101 101
Device Operates Differently Than Expected 88 88
Difficult to Insert 86 86
Inadequacy of Device Shape and/or Size 86 86
Patient-Device Incompatibility 74 74
Device Packaging Compromised 73 73
Device-Device Incompatibility 70 70
Unintended Movement 68 68
Compatibility Problem 66 66
Detachment of Device or Device Component 66 66
Failure to Osseointegrate 64 64
Mechanical Problem 61 61
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
No Apparent Adverse Event 36 36
Separation Problem 36 36
Failure To Adhere Or Bond 35 35
Material Deformation 28 28
Patient Device Interaction Problem 28 28
Material Separation 24 24
Material Integrity Problem 21 21
Delivered as Unsterile Product 19 19
Manufacturing, Packaging or Shipping Problem 18 18
Disconnection 17 17
Difficult To Position 17 17
Material Twisted/Bent 17 17
Mechanical Jam 17 17
Defective Device 16 16
Off-Label Use 16 16
Detachment Of Device Component 16 16
Scratched Material 16 16
Component Missing 15 15
Material Discolored 13 13
Unsealed Device Packaging 11 11
Difficult or Delayed Separation 11 11
Problem with Sterilization 10 10
Crack 10 10
Material Fragmentation 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
Flaked 8 8
Entrapment of Device 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
Difficult to Open or Remove Packaging Material 4 4
Therapeutic or Diagnostic Output Failure 3 3
Fluid Leak 3 3
Incomplete or Missing Packaging 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 3 3
Dull, Blunt 2 2
Product Quality Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 16120 16121
No Code Available 12153 12155
No Information 4654 4654
Foreign Body Reaction 4406 4406
Discomfort 3170 3170
Test Result 3152 3152
Unspecified Infection 2890 2891
Tissue Damage 2798 2798
Reaction 2462 2462
Osteolysis 2405 2405
Host-Tissue Reaction 2322 2322
Injury 2257 2257
Joint Dislocation 2083 2083
Limited Mobility Of The Implanted Joint 1894 1894
Not Applicable 1593 1593
Inadequate Osseointegration 1588 1589
Inflammation 1519 1519
Hypersensitivity/Allergic reaction 1233 1233
Bone Fracture(s) 1138 1138
Loss of Range of Motion 998 998
Ambulation Difficulties 807 807
Necrosis 717 717
Weakness 658 658
Edema 650 650
Swelling 628 628
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 620 620
No Known Impact Or Consequence To Patient 571 571
Distress 568 568
No Consequences Or Impact To Patient 526 526
No Patient Involvement 514 514
Synovitis 434 434
Cyst(s) 427 427
Adhesion(s) 411 411
Anxiety 281 281
Local Reaction 280 280
Toxicity 270 270
Failure of Implant 261 261
Muscular Rigidity 239 239
Fall 231 231
Scar Tissue 221 221
Ossification 218 218
Hematoma 218 218
Fatigue 216 216
Metal Related Pathology 195 195
Fluid Discharge 191 191
Thrombosis 176 176
Insufficient Information 172 172
Joint Disorder 171 171
Deformity/ Disfigurement 167 167
Hip Fracture 149 149
Blood Loss 140 140
Swelling/ Edema 139 139
Pulmonary Embolism 138 138
No Clinical Signs, Symptoms or Conditions 123 123
Death 106 106
Hemorrhage/Bleeding 104 104
Depression 95 95
Erosion 95 95
Fibrosis 89 89
Scarring 84 84
Nerve Damage 80 80
Hypoesthesia 80 80
Unspecified Tissue Injury 78 78
Joint Swelling 76 76
Wound Dehiscence 76 76
Osteopenia/ Osteoporosis 72 72
Joint Laxity 69 69
Pocket Erosion 69 69
Cardiac Arrest 68 68
Infarction, Cerebral 60 60
Irritation 59 59
Sepsis 58 58
Fever 57 57
Myocardial Infarction 55 55
Rash 53 53
Abscess 52 52
Headache 52 52
Impaired Healing 47 47
Calcium Deposits/Calcification 45 45
Skin Irritation 45 45
Physical Asymmetry 43 43
Numbness 41 41
Foreign Body In Patient 36 36
Stroke/CVA 36 36
Complaint, Ill-Defined 35 35
Memory Loss/Impairment 35 35
Hearing Impairment 35 35
Post Operative Wound Infection 32 32
Tinnitus 32 32
Nausea 31 31
Bacterial Infection 31 31
Renal Failure 30 30
Burning Sensation 29 29
Anemia 28 28
Heart Failure 25 25
Arthralgia 24 24
Patient Problem/Medical Problem 24 24
Itching Sensation 24 24
Sleep Dysfunction 24 24
Neuropathy 23 23

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
8 Zimmer Biomet, Inc. II Feb-22-2016
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