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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
2019 7635 7635
2020 4536 4536
2021 2063 2063
2022 1620 1620
2023 1482 1482
2024 582 582

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8142 8142
Device Dislodged or Dislocated 1903 1903
Naturally Worn 1886 1886
Loss of Osseointegration 1034 1034
Insufficient Information 1033 1033
Osseointegration Problem 614 614
Fracture 611 611
Material Erosion 537 537
Device Contaminated During Manufacture or Shipping 520 520
Migration 466 466
Corroded 416 416
Use of Device Problem 360 360
Biocompatibility 325 325
Noise, Audible 311 311
Malposition of Device 291 291
Loosening of Implant Not Related to Bone-Ingrowth 227 227
Appropriate Term/Code Not Available 215 215
Degraded 207 207
Packaging Problem 181 181
Patient Device Interaction Problem 170 170
Loss of or Failure to Bond 168 168
Nonstandard Device 153 153
Material Disintegration 140 140
Tear, Rip or Hole in Device Packaging 139 139
Difficult to Insert 135 135
Unstable 116 116
Break 92 92
Manufacturing, Packaging or Shipping Problem 88 88
Patient-Device Incompatibility 71 71
Difficult to Remove 67 67
Detachment of Device or Device Component 66 66
Unintended Movement 66 66
Inadequacy of Device Shape and/or Size 62 62
Device-Device Incompatibility 61 61
Loose or Intermittent Connection 51 51
Positioning Failure 50 50
Separation Failure 38 38
No Apparent Adverse Event 36 36
Failure to Osseointegrate 32 32
Off-Label Use 31 31
Migration or Expulsion of Device 27 27
Material Integrity Problem 21 21
Mechanical Problem 20 20
Delivered as Unsterile Product 20 20
Separation Problem 17 17
Mechanical Jam 15 15
Material Twisted/Bent 14 14
Positioning Problem 13 13
Material Deformation 13 13
Physical Resistance/Sticking 13 13
Fitting Problem 13 13
Difficult or Delayed Separation 11 11
Scratched Material 10 10
Problem with Sterilization 10 10
Improper or Incorrect Procedure or Method 9 9
Flaked 8 8
Material Fragmentation 8 8
Illegible Information 8 8
Inaccurate Information 7 7
Output Problem 7 7
Unsealed Device Packaging 7 7
Shipping Damage or Problem 7 7
Material Separation 6 6
Defective Device 6 6
Contamination /Decontamination Problem 6 6
Expiration Date Error 5 5
Difficult or Delayed Positioning 5 5
Difficult to Open or Remove Packaging Material 5 5
Missing Information 4 4
Peeled/Delaminated 4 4
Device Markings/Labelling Problem 4 4
Device Damaged Prior to Use 4 4
Difficult to Advance 3 3
Activation, Positioning or Separation Problem 3 3
Biofilm coating in Device 3 3
Misassembled 3 3
Material Discolored 3 3
Entrapment of Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Human-Device Interface Problem 2 2
Disconnection 2 2
Crack 2 2
Collapse 2 2
Device Difficult to Setup or Prepare 2 2
Device Appears to Trigger Rejection 2 2
Failure to Disconnect 2 2
Connection Problem 2 2
Defective Component 2 2
Component Missing 2 2
Incomplete or Missing Packaging 2 2
Failure to Align 1 1
Microbial Contamination of Device 1 1
Vibration 1 1
Device Slipped 1 1
Failure to Fire 1 1
Device Ingredient or Reagent Problem 1 1
Device Damaged by Another Device 1 1
Particulates 1 1
Component Incompatible 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 7829 7831
Pain 7265 7265
Foreign Body Reaction 3007 3007
Test Result 2244 2244
Unspecified Infection 2119 2120
Osteolysis 1497 1497
Joint Dislocation 1493 1493
Metal Related Pathology 1401 1401
Inadequate Osseointegration 1296 1296
Tissue Damage 1286 1286
Hypersensitivity/Allergic reaction 1197 1197
Discomfort 1147 1147
Injury 850 850
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 837 837
No Information 740 740
Limited Mobility Of The Implanted Joint 729 729
Bone Fracture(s) 721 721
Loss of Range of Motion 631 631
Inflammation 605 605
No Clinical Signs, Symptoms or Conditions 580 580
Insufficient Information 556 556
Necrosis 518 518
Ambulation Difficulties 488 488
Swelling/ Edema 473 473
Reaction 472 472
Edema 465 465
Failure of Implant 455 455
Distress 451 451
Unspecified Tissue Injury 414 414
No Patient Involvement 375 375
Adhesion(s) 374 374
No Known Impact Or Consequence To Patient 335 335
Scar Tissue 274 274
Synovitis 273 273
Joint Laxity 272 272
Deformity/ Disfigurement 252 252
Cyst(s) 235 235
Anxiety 226 226
No Consequences Or Impact To Patient 226 226
Fatigue 224 224
Swelling 208 208
Weakness 201 201
Fall 199 199
Not Applicable 186 186
Local Reaction 185 185
Host-Tissue Reaction 177 177
Ossification 161 161
Hematoma 147 147
Thrombosis 143 143
Muscular Rigidity 130 130
Hemorrhage/Bleeding 126 126
Muscle/Tendon Damage 123 123
Pulmonary Embolism 122 122
Depression 112 112
Physical Asymmetry 97 97
Osteopenia/ Osteoporosis 94 94
Pocket Erosion 86 86
Joint Disorder 80 80
Nerve Damage 69 69
Numbness 68 68
Wound Dehiscence 62 62
Erosion 59 59
Fibrosis 51 51
Abscess 49 49
Cardiac Arrest 45 45
Memory Loss/Impairment 45 45
Myocardial Infarction 44 44
Blood Loss 44 44
Hypoesthesia 43 43
Rash 42 42
Fever 42 42
Sepsis 41 41
Fluid Discharge 41 41
Death 38 38
Limb Fracture 37 37
Stroke/CVA 35 35
Renal Failure 34 34
Scarring 33 33
Toxicity 32 32
Headache 31 31
Hearing Impairment 30 30
Impaired Healing 30 30
Infarction, Cerebral 29 29
Bacterial Infection 27 27
Tinnitus 26 26
Foreign Body In Patient 26 26
Unspecified Musculoskeletal problem 26 26
Dizziness 25 25
Calcium Deposits/Calcification 25 25
Thrombosis/Thrombus 24 24
Post Operative Wound Infection 22 22
Anemia 21 21
Dyspnea 20 20
Unequal Limb Length 20 20
Arthralgia 19 19
Heart Failure 19 19
Itching Sensation 19 19
Erythema 18 18
Atrial Fibrillation 18 18
Pneumonia 17 17

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 Zimmer Biomet, Inc. II Nov-07-2019
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