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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 7633 7633
2020 4536 4536
2021 2063 2063
2022 1620 1620
2023 1478 1478
2024 378 378

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8036 8036
Device Dislodged or Dislocated 1887 1887
Naturally Worn 1872 1872
Loss of Osseointegration 1033 1033
Insufficient Information 1026 1026
Fracture 609 609
Osseointegration Problem 605 605
Material Erosion 523 523
Device Contaminated During Manufacture or Shipping 520 520
Migration 462 462
Corroded 415 415
Use of Device Problem 355 355
Biocompatibility 320 320
Noise, Audible 307 307
Malposition of Device 290 290
Loosening of Implant Not Related to Bone-Ingrowth 226 226
Appropriate Term/Code Not Available 215 215
Degraded 205 205
Packaging Problem 178 178
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 137 137
Difficult to Insert 127 127
Unstable 116 116
Break 92 92
Manufacturing, Packaging or Shipping Problem 77 77
Patient-Device Incompatibility 71 71
Detachment of Device or Device Component 66 66
Unintended Movement 66 66
Difficult to Remove 65 65
Inadequacy of Device Shape and/or Size 61 61
Device-Device Incompatibility 59 59
Loose or Intermittent Connection 51 51
Positioning Failure 50 50
Separation Failure 36 36
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 17 17
Separation Problem 15 15
Mechanical Jam 15 15
Material Twisted/Bent 14 14
Fitting Problem 13 13
Physical Resistance/Sticking 13 13
Material Deformation 13 13
Positioning Problem 13 13
Difficult or Delayed Separation 11 11
Problem with Sterilization 10 10
Scratched Material 10 10
Improper or Incorrect Procedure or Method 9 9
Illegible Information 8 8
Flaked 8 8
Material Fragmentation 8 8
Inaccurate Information 7 7
Unsealed Device Packaging 7 7
Output Problem 7 7
Shipping Damage or Problem 7 7
Contamination /Decontamination Problem 6 6
Defective Device 6 6
Material Separation 6 6
Difficult to Open or Remove Packaging Material 5 5
Difficult or Delayed Positioning 5 5
Expiration Date Error 5 5
Missing Information 4 4
Device Damaged Prior to Use 4 4
Device Markings/Labelling Problem 4 4
Peeled/Delaminated 4 4
Entrapment of Device 3 3
Difficult to Advance 3 3
Material Discolored 3 3
Misassembled 3 3
Biofilm coating in Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Activation, Positioning or Separation Problem 3 3
Component Missing 2 2
Device Difficult to Setup or Prepare 2 2
Connection Problem 2 2
Defective Component 2 2
Device Appears to Trigger Rejection 2 2
Human-Device Interface Problem 2 2
Disconnection 2 2
Failure to Disconnect 2 2
Collapse 2 2
Crack 2 2
Incomplete or Missing Packaging 2 2
Device Handling Problem 1 1
Material Protrusion/Extrusion 1 1
Component Incompatible 1 1
Device Damaged by Another Device 1 1
Device Contamination with Chemical or Other Material 1 1
Microbial Contamination of Device 1 1
Failure to Align 1 1
Device Slipped 1 1
Contamination 1 1
Device Ingredient or Reagent Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 7827 7829
Pain 7202 7202
Foreign Body Reaction 2970 2970
Test Result 2243 2243
Unspecified Infection 2099 2100
Joint Dislocation 1479 1479
Osteolysis 1479 1479
Metal Related Pathology 1337 1337
Inadequate Osseointegration 1290 1290
Tissue Damage 1286 1286
Hypersensitivity/Allergic reaction 1176 1176
Discomfort 1141 1141
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) 711 711
Loss of Range of Motion 628 628
Inflammation 600 600
No Clinical Signs, Symptoms or Conditions 546 546
Insufficient Information 539 539
Necrosis 515 515
Ambulation Difficulties 484 484
Reaction 472 472
Edema 465 465
Swelling/ Edema 458 458
Failure of Implant 451 451
Distress 444 444
Unspecified Tissue Injury 389 389
No Patient Involvement 375 375
Adhesion(s) 372 372
No Known Impact Or Consequence To Patient 335 335
Scar Tissue 270 270
Synovitis 265 265
Joint Laxity 260 260
Deformity/ Disfigurement 252 252
Cyst(s) 234 234
Anxiety 226 226
No Consequences Or Impact To Patient 226 226
Fatigue 223 223
Swelling 208 208
Weakness 201 201
Fall 196 196
Not Applicable 186 186
Local Reaction 185 185
Host-Tissue Reaction 177 177
Ossification 161 161
Hematoma 145 145
Thrombosis 143 143
Muscular Rigidity 129 129
Hemorrhage/Bleeding 125 125
Muscle/Tendon Damage 123 123
Pulmonary Embolism 122 122
Depression 112 112
Physical Asymmetry 96 96
Osteopenia/ Osteoporosis 92 92
Pocket Erosion 86 86
Joint Disorder 80 80
Nerve Damage 69 69
Numbness 67 67
Wound Dehiscence 62 62
Erosion 59 59
Fibrosis 51 51
Abscess 48 48
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 40 40
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
Dizziness 25 25
Calcium Deposits/Calcification 25 25
Foreign Body In Patient 25 25
Thrombosis/Thrombus 24 24
Unspecified Musculoskeletal problem 23 23
Post Operative Wound Infection 22 22
Anemia 21 21
Dyspnea 20 20
Heart Failure 19 19
Itching Sensation 19 19
Arthralgia 19 19
Unequal Limb Length 18 18
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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