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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
2016 7869 7869
2017 6843 6843
2018 6387 6387
2019 7633 7633
2020 4536 4536
2021 2063 2063
2022 1620 1620
2023 1478 1478
2024 292 292

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 10301 10301
Adverse Event Without Identified Device or Use Problem 9999 9999
Appropriate Term/Code Not Available 4664 4664
Naturally Worn 3610 3610
Device Dislodged or Dislocated 3211 3211
Loss of Osseointegration 1934 1934
Material Erosion 1347 1347
Metal Shedding Debris 1313 1313
Corroded 1201 1201
Fracture 960 960
Noise, Audible 812 812
Migration or Expulsion of Device 749 749
Osseointegration Problem 716 716
Malposition of Device 608 608
Device Contaminated During Manufacture or Shipping 566 566
Migration 534 534
Material Disintegration 511 511
Nonstandard Device 437 437
Loose or Intermittent Connection 409 409
Use of Device Problem 383 383
Biocompatibility 366 366
Break 303 303
Degraded 282 282
Unstable 261 261
Loosening of Implant Not Related to Bone-Ingrowth 254 254
Loss of or Failure to Bond 246 246
Packaging Problem 216 216
Tear, Rip or Hole in Device Packaging 176 176
Patient Device Interaction Problem 175 175
Disassembly 174 174
Difficult to Remove 156 156
Difficult to Insert 138 138
Separation Failure 112 112
Patient-Device Incompatibility 111 111
Inadequacy of Device Shape and/or Size 96 96
Detachment of Device or Device Component 88 88
Device Operates Differently Than Expected 88 88
Device-Device Incompatibility 83 83
Manufacturing, Packaging or Shipping Problem 78 78
Unintended Movement 74 74
Device Packaging Compromised 73 73
Mechanical Problem 68 68
Failure to Osseointegrate 66 66
Compatibility Problem 66 66
Positioning Problem 57 57
Positioning Failure 51 51
No Apparent Adverse Event 47 47
Fitting Problem 44 44
Device Contamination with Chemical or Other Material 40 40
Device Slipped 39 39
Material Integrity Problem 38 38
Separation Problem 36 36
Failure To Adhere Or Bond 35 35
Material Deformation 34 34
Off-Label Use 34 34
Material Separation 24 24
Delivered as Unsterile Product 22 22
Mechanical Jam 21 21
Difficult To Position 17 17
Defective Device 17 17
Disconnection 17 17
Scratched Material 17 17
Material Twisted/Bent 17 17
Component Missing 16 16
Detachment Of Device Component 16 16
Physical Resistance/Sticking 14 14
Material Discolored 14 14
Improper or Incorrect Procedure or Method 14 14
Unsealed Device Packaging 13 13
Material Fragmentation 11 11
Difficult or Delayed Separation 11 11
Problem with Sterilization 10 10
Flaked 10 10
Device Markings/Labelling Problem 10 10
Crack 10 10
Component or Accessory Incompatibility 9 9
Peeled/Delaminated 9 9
Illegible Information 8 8
Shipping Damage or Problem 7 7
Inaccurate Information 7 7
Output Problem 7 7
Entrapment of Device 7 7
Failure to Disconnect 6 6
Connection Problem 6 6
Contamination /Decontamination Problem 6 6
Difficult or Delayed Positioning 5 5
Therapeutic or Diagnostic Output Failure 5 5
Expiration Date Error 5 5
Improper Chemical Reaction 5 5
Difficult to Open or Remove Packaging Material 5 5
Collapse 4 4
Difficult to Advance 4 4
Device Damaged Prior to Use 4 4
Bent 4 4
Defective Component 4 4
Missing Information 4 4
Misassembled 4 4
Biofilm coating in Device 3 3
Activation, Positioning or Separation Problem 3 3
Fluid/Blood Leak 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 17693 17694
No Code Available 12155 12157
Foreign Body Reaction 5267 5267
No Information 4651 4651
Discomfort 3510 3510
Unspecified Infection 3352 3353
Test Result 3157 3157
Tissue Damage 2802 2802
Osteolysis 2718 2718
Reaction 2459 2459
Joint Dislocation 2398 2398
Host-Tissue Reaction 2320 2320
Injury 2257 2257
Limited Mobility Of The Implanted Joint 1897 1897
Inadequate Osseointegration 1739 1740
Inflammation 1653 1653
Not Applicable 1595 1595
Hypersensitivity/Allergic reaction 1576 1576
Metal Related Pathology 1430 1430
Loss of Range of Motion 1281 1281
Bone Fracture(s) 1248 1248
Ambulation Difficulties 1060 1060
Distress 915 915
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 907 907
Necrosis 863 863
Weakness 661 661
Edema 649 649
Swelling 629 629
Failure of Implant 577 577
No Known Impact Or Consequence To Patient 571 571
Synovitis 559 559
No Clinical Signs, Symptoms or Conditions 543 543
Insufficient Information 539 539
No Consequences Or Impact To Patient 526 526
Adhesion(s) 521 521
No Patient Involvement 514 514
Cyst(s) 497 497
Swelling/ Edema 487 487
Unspecified Tissue Injury 430 430
Anxiety 421 421
Scar Tissue 385 385
Deformity/ Disfigurement 372 372
Fatigue 322 322
Fall 321 321
Muscular Rigidity 307 307
Local Reaction 297 297
Toxicity 270 270
Ossification 267 267
Joint Laxity 262 262
Hematoma 240 240
Fluid Discharge 211 211
Thrombosis 176 176
Depression 171 171
Joint Disorder 171 171
Hip Fracture 149 149
Pulmonary Embolism 147 147
Hemorrhage/Bleeding 141 141
Blood Loss 140 140
Muscle/Tendon Damage 129 129
Pocket Erosion 112 112
Osteopenia/ Osteoporosis 110 110
Fibrosis 108 108
Physical Asymmetry 106 106
Death 106 106
Nerve Damage 105 105
Erosion 103 103
Numbness 95 95
Wound Dehiscence 89 89
Scarring 84 84
Hypoesthesia 80 80
Joint Swelling 76 76
Cardiac Arrest 73 73
Rash 70 70
Abscess 66 66
Fever 66 66
Headache 62 62
Memory Loss/Impairment 61 61
Sepsis 60 60
Infarction, Cerebral 60 60
Irritation 59 59
Impaired Healing 56 56
Myocardial Infarction 55 55
Bacterial Infection 49 49
Calcium Deposits/Calcification 47 47
Skin Irritation 46 46
Hearing Impairment 45 45
Foreign Body In Patient 44 44
Post Operative Wound Infection 44 44
Stroke/CVA 40 40
Tinnitus 39 39
Limb Fracture 38 38
Renal Failure 38 38
Anemia 35 35
Dizziness 35 35
Complaint, Ill-Defined 35 35
Arthralgia 34 34
Nausea 33 33
Burning Sensation 32 32
Confusion/ Disorientation 30 30
Itching Sensation 30 30

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Nov-21-2023
2 Biomet, Inc. II Aug-12-2021
3 DePuy Orthopaedics, Inc. II Jan-07-2021
4 Encore Medical, LP II Sep-19-2023
5 Encore Medical, Lp II Feb-11-2017
6 Zimmer Biomet, Inc. II Nov-07-2019
7 Zimmer Biomet, Inc. II Dec-19-2018
8 Zimmer Biomet, Inc. II Aug-14-2018
9 Zimmer Biomet, Inc. II Dec-29-2017
10 Zimmer Biomet, Inc. II Feb-22-2016
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