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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
2018 6388 6388
2019 7632 7632
2020 4535 4535
2021 2060 2060
2022 1623 1623
2023 1074 1074

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8754 8754
Insufficient Information 3281 3281
Naturally Worn 2440 2440
Device Dislodged or Dislocated 2244 2244
Loss of Osseointegration 1196 1196
Appropriate Term/Code Not Available 1105 1105
Material Erosion 805 805
Fracture 726 726
Osseointegration Problem 642 642
Corroded 634 634
Device Contaminated During Manufacture or Shipping 561 561
Migration 507 507
Noise, Audible 400 400
Malposition of Device 373 373
Use of Device Problem 352 352
Biocompatibility 340 340
Material Disintegration 274 274
Migration or Expulsion of Device 242 242
Degraded 239 239
Nonstandard Device 234 234
Loosening of Implant Not Related to Bone-Ingrowth 229 229
Packaging Problem 201 201
Loss of or Failure to Bond 190 190
Loose or Intermittent Connection 182 182
Unstable 171 171
Tear, Rip or Hole in Device Packaging 167 167
Patient Device Interaction Problem 167 167
Metal Shedding Debris 163 163
Break 147 147
Difficult to Insert 120 120
Difficult to Remove 90 90
Detachment of Device or Device Component 79 79
Inadequacy of Device Shape and/or Size 76 76
Separation Failure 75 75
Patient-Device Incompatibility 73 73
Device-Device Incompatibility 72 72
Unintended Movement 68 68
Manufacturing, Packaging or Shipping Problem 62 62
Device Packaging Compromised 58 58
Disassembly 58 58
Failure to Osseointegrate 57 57
Positioning Failure 49 49
No Apparent Adverse Event 46 46
Device Contamination with Chemical or Other Material 36 36
Separation Problem 36 36
Off-Label Use 31 31
Fitting Problem 30 30
Material Deformation 26 26
Material Integrity Problem 22 22
Positioning Problem 21 21
Delivered as Unsterile Product 20 20
Mechanical Problem 19 19
Material Twisted/Bent 17 17
Mechanical Jam 17 17
Disconnection 16 16
Material Separation 16 16
Physical Resistance/Sticking 12 12
Difficult or Delayed Separation 11 11
Scratched Material 11 11
Problem with Sterilization 10 10
Improper or Incorrect Procedure or Method 10 10
Material Fragmentation 10 10
Flaked 9 9
Unsealed Device Packaging 9 9
Failure To Adhere Or Bond 9 9
Defective Device 8 8
Difficult To Position 8 8
Illegible Information 8 8
Inaccurate Information 7 7
Output Problem 7 7
Device Markings/Labelling Problem 7 7
Peeled/Delaminated 7 7
Shipping Damage or Problem 7 7
Material Discolored 7 7
Contamination /Decontamination Problem 6 6
Connection Problem 5 5
Device Operates Differently Than Expected 5 5
Difficult to Open or Remove Packaging Material 5 5
Difficult or Delayed Positioning 5 5
Crack 5 5
Expiration Date Error 5 5
Component Missing 5 5
Device Damaged Prior to Use 4 4
Misassembled 4 4
Missing Information 4 4
Difficult to Advance 3 3
Activation, Positioning or Separation Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Entrapment of Device 3 3
Biofilm coating in Device 3 3
Defective Component 3 3
Incomplete or Missing Packaging 3 3
Failure to Disconnect 3 3
Device Slipped 3 3
Device Difficult to Setup or Prepare 2 2
Device Appears to Trigger Rejection 2 2
Material Rupture 2 2
Dull, Blunt 2 2
Failure to Align 2 2
Bent 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 9907 9908
No Code Available 9468 9470
Foreign Body Reaction 3243 3243
Test Result 3014 3014
Unspecified Infection 2555 2556
Tissue Damage 2119 2119
Joint Dislocation 1811 1811
Osteolysis 1795 1795
Discomfort 1795 1795
Injury 1682 1682
Inadequate Osseointegration 1577 1578
No Information 1398 1398
Not Applicable 1369 1369
Hypersensitivity/Allergic reaction 1286 1286
Metal Related Pathology 1206 1206
Limited Mobility Of The Implanted Joint 1204 1204
Reaction 1100 1100
Inflammation 958 958
Bone Fracture(s) 900 900
Loss of Range of Motion 881 881
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 874 874
Distress 760 760
Ambulation Difficulties 651 651
Necrosis 647 647
Host-Tissue Reaction 614 614
Edema 584 584
No Patient Involvement 503 503
No Clinical Signs, Symptoms or Conditions 475 475
Adhesion(s) 459 459
Insufficient Information 454 454
Failure of Implant 444 444
No Consequences Or Impact To Patient 428 428
No Known Impact Or Consequence To Patient 424 424
Weakness 418 418
Swelling/ Edema 405 405
Swelling 367 367
Unspecified Tissue Injury 358 358
Anxiety 330 330
Cyst(s) 326 326
Scar Tissue 321 321
Deformity/ Disfigurement 317 317
Synovitis 315 315
Fatigue 258 258
Local Reaction 239 239
Joint Laxity 225 225
Fall 216 216
Ossification 191 191
Hematoma 187 187
Muscular Rigidity 168 168
Thrombosis 166 166
Pulmonary Embolism 139 139
Depression 136 136
Blood Loss 129 129
Joint Disorder 127 127
Hemorrhage/Bleeding 126 126
Osteopenia/ Osteoporosis 101 101
Physical Asymmetry 94 94
Pocket Erosion 94 94
Muscle/Tendon Damage 90 90
Fibrosis 79 79
Nerve Damage 79 79
Erosion 77 77
Wound Dehiscence 74 74
Hip Fracture 66 66
Numbness 64 64
Fluid Discharge 62 62
Cardiac Arrest 60 60
Hypoesthesia 59 59
Death 56 56
Fever 54 54
Scarring 54 54
Memory Loss/Impairment 53 53
Abscess 53 53
Toxicity 53 53
Impaired Healing 51 51
Rash 51 51
Sepsis 51 51
Myocardial Infarction 48 48
Infarction, Cerebral 44 44
Bacterial Infection 41 41
Headache 41 41
Stroke/CVA 39 39
Post Operative Wound Infection 39 39
Calcium Deposits/Calcification 37 37
Renal Failure 36 36
Limb Fracture 36 36
Foreign Body In Patient 35 35
Tinnitus 32 32
Hearing Impairment 32 32
Anemia 29 29
Confusion/ Disorientation 27 27
Dizziness 24 24
Burning Sensation 23 23
Heart Failure 22 22
Thrombosis/Thrombus 22 22
Unspecified Musculoskeletal problem 21 21
Arthralgia 20 20
Neuropathy 20 20
Nausea 20 20
Itching Sensation 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 Sep-19-2023
4 Zimmer Biomet, Inc. II Nov-07-2019
5 Zimmer Biomet, Inc. II Dec-19-2018
6 Zimmer Biomet, Inc. II Aug-14-2018
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