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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
2017 6842 6842
2018 6388 6388
2019 7632 7632
2020 4541 4541
2021 2071 2071

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7765 7765
Insufficient Information 6689 6689
Naturally Worn 2697 2697
Appropriate Term/Code Not Available 2471 2471
Device Dislodged or Dislocated 2457 2457
Loss of Osseointegration 1490 1490
Corroded 853 853
Material Erosion 842 842
Fracture 706 706
Metal Shedding Debris 668 668
Osseointegration Problem 572 572
Device Contaminated During Manufacture or Shipping 552 552
Migration or Expulsion of Device 516 516
Noise, Audible 468 468
Migration 465 465
Malposition of Device 456 456
Nonstandard Device 411 411
Material Disintegration 403 403
Biocompatibility 311 311
Use of Device Problem 305 305
Loose or Intermittent Connection 261 261
Loss of or Failure to Bond 219 219
Degraded 214 214
Unstable 208 208
Break 195 195
Packaging Problem 159 159
Loosening of Implant Not Related to Bone-Ingrowth 157 157
Tear, Rip or Hole in Device Packaging 129 129
Disassembly 123 123
Difficult to Remove 107 107
Difficult to Insert 96 96
Separation Failure 77 77
Inadequacy of Device Shape and/or Size 71 71
Device-Device Incompatibility 69 69
Unintended Movement 69 69
Device Packaging Compromised 68 68
Detachment of Device or Device Component 66 66
Failure to Osseointegrate 58 58
Patient Device Interaction Problem 50 50
Patient-Device Incompatibility 47 47
Positioning Failure 42 42
Device Contamination with Chemical or Other Material 38 38
No Apparent Adverse Event 37 37
Fitting Problem 37 37
Separation Problem 36 36
Positioning Problem 29 29
Mechanical Problem 28 28
Manufacturing, Packaging or Shipping Problem 25 25
Material Deformation 25 25
Material Separation 23 23
Delivered as Unsterile Product 19 19
Failure To Adhere Or Bond 19 19
Disconnection 17 17
Off-Label Use 17 17
Material Twisted/Bent 17 17
Mechanical Jam 16 16
Compatibility Problem 16 16
Material Integrity Problem 15 15
Scratched Material 15 15
Component Missing 15 15
Difficult To Position 14 14
Defective Device 14 14
Device Operates Differently Than Expected 13 13
Difficult or Delayed Separation 10 10
Problem with Sterilization 10 10
Unsealed Device Packaging 9 9
Flaked 9 9
Material Fragmentation 9 9
Material Discolored 8 8
Device Markings/Labelling Problem 8 8
Crack 7 7
Peeled/Delaminated 7 7
Device Slipped 7 7
Shipping Damage or Problem 6 6
Detachment Of Device Component 6 6
Illegible Information 6 6
Physical Resistance/Sticking 5 5
Contamination /Decontamination Problem 5 5
Connection Problem 5 5
Difficult to Open or Remove Packaging Material 5 5
Entrapment of Device 5 5
Improper or Incorrect Procedure or Method 5 5
Misassembled 4 4
Expiration Date Error 4 4
Failure to Disconnect 3 3
Difficult to Advance 3 3
Missing Information 3 3
Therapeutic or Diagnostic Output Failure 3 3
Bent 3 3
Biofilm coating in Device 3 3
Collapse 3 3
Difficult or Delayed Positioning 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
Inaccurate Information 2 2
Activation, Positioning or SeparationProblem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 12095 12096
No Code Available 10566 10568
Foreign Body Reaction 3491 3491
Test Result 3083 3083
No Information 3019 3019
Unspecified Infection 2616 2617
Tissue Damage 2500 2500
Discomfort 2225 2225
Injury 2020 2020
Joint Dislocation 1957 1957
Osteolysis 1957 1957
Reaction 1783 1783
Inadequate Osseointegration 1582 1583
Limited Mobility Of The Implanted Joint 1560 1560
Not Applicable 1497 1497
Host-Tissue Reaction 1354 1354
Hypersensitivity/Allergic reaction 1186 1186
Inflammation 1181 1181
Bone Fracture(s) 980 980
Loss of Range of Motion 833 833
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 735 735
Ambulation Difficulties 724 724
Necrosis 641 641
Edema 627 627
Distress 561 561
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) 403 403
Cyst(s) 374 374
Synovitis 314 314
Metal Related Pathology 269 269
Local Reaction 266 266
Anxiety 265 265
Failure of Implant 259 259
Insufficient Information 242 242
Scar Tissue 213 213
Fatigue 211 211
Hematoma 205 205
Muscular Rigidity 195 195
Ossification 191 191
No Clinical Signs, Symptoms or Conditions 188 188
Swelling/ Edema 182 182
Fall 181 181
Thrombosis 175 175
Deformity/ Disfigurement 173 173
Joint Disorder 147 147
Fluid Discharge 137 137
Pulmonary Embolism 135 135
Blood Loss 134 134
Hip Fracture 114 114
Unspecified Tissue Injury 112 112
Hemorrhage/Bleeding 106 106
Joint Laxity 93 93
Depression 89 89
Erosion 85 85
Toxicity 82 82
Death 77 77
Osteopenia/ Osteoporosis 76 76
Fibrosis 75 75
Nerve Damage 75 75
Pocket Erosion 74 74
Scarring 73 73
Wound Dehiscence 73 73
Hypoesthesia 69 69
Cardiac Arrest 62 62
Infarction, Cerebral 57 57
Sepsis 55 55
Myocardial Infarction 54 54
Fever 54 54
Rash 52 52
Abscess 49 49
Impaired Healing 49 49
Physical Asymmetry 48 48
Headache 45 45
Calcium Deposits/Calcification 41 41
Irritation 39 39
Memory Loss/Impairment 37 37
Stroke/CVA 36 36
Skin Irritation 35 35
Foreign Body In Patient 35 35
Numbness 32 32
Renal Failure 30 30
Hearing Impairment 30 30
Bacterial Infection 29 29
Anemia 29 29
Tinnitus 29 29
Joint Swelling 27 27
Post Operative Wound Infection 27 27
Burning Sensation 27 27
Muscle/Tendon Damage 26 26
Nausea 24 24
Neuropathy 23 23
Itching Sensation 23 23
Heart Failure 23 23
Muscle Spasm(s) 22 22
Patient Problem/Medical Problem 21 21
Atrial Fibrillation 20 20

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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