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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 6394 6394
2019 7640 7640
2020 4545 4545
2021 2079 2079
2022 1675 1675

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8210 8210
Insufficient Information 3282 3282
Naturally Worn 2321 2321
Device Dislodged or Dislocated 2159 2159
Loss of Osseointegration 1195 1195
Appropriate Term/Code Not Available 1107 1107
Material Erosion 789 789
Fracture 683 683
Corroded 621 621
Osseointegration Problem 606 606
Device Contaminated During Manufacture or Shipping 560 560
Migration 501 501
Malposition of Device 376 376
Noise, Audible 373 373
Use of Device Problem 330 330
Biocompatibility 311 311
Material Disintegration 274 274
Migration or Expulsion of Device 242 242
Nonstandard Device 233 233
Degraded 223 223
Loosening of Implant Not Related to Bone-Ingrowth 208 208
Loss of or Failure to Bond 191 191
Packaging Problem 186 186
Loose or Intermittent Connection 182 182
Unstable 169 169
Metal Shedding Debris 163 163
Tear, Rip or Hole in Device Packaging 160 160
Break 146 146
Patient Device Interaction Problem 113 113
Difficult to Insert 105 105
Difficult to Remove 83 83
Detachment of Device or Device Component 79 79
Separation Failure 75 75
Device-Device Incompatibility 73 73
Inadequacy of Device Shape and/or Size 71 71
Unintended Movement 69 69
Device Packaging Compromised 58 58
Disassembly 58 58
Failure to Osseointegrate 57 57
Patient-Device Incompatibility 53 53
Positioning Failure 47 47
No Apparent Adverse Event 43 43
Device Contamination with Chemical or Other Material 36 36
Separation Problem 36 36
Manufacturing, Packaging or Shipping Problem 32 32
Fitting Problem 30 30
Off-Label Use 28 28
Material Deformation 26 26
Material Integrity Problem 24 24
Positioning Problem 20 20
Mechanical Problem 19 19
Delivered as Unsterile Product 19 19
Material Separation 17 17
Material Twisted/Bent 17 17
Mechanical Jam 17 17
Disconnection 16 16
Scratched Material 11 11
Difficult or Delayed Separation 11 11
Material Fragmentation 10 10
Problem with Sterilization 10 10
Improper or Incorrect Procedure or Method 9 9
Flaked 9 9
Unsealed Device Packaging 9 9
Failure To Adhere Or Bond 9 9
Difficult To Position 8 8
Defective Device 8 8
Output Problem 8 8
Device Markings/Labelling Problem 7 7
Illegible Information 7 7
Physical Resistance/Sticking 7 7
Shipping Damage or Problem 7 7
Material Discolored 7 7
Peeled/Delaminated 6 6
Inaccurate Information 6 6
Contamination /Decontamination Problem 6 6
Difficult to Open or Remove Packaging Material 6 6
Connection Problem 5 5
Device Operates Differently Than Expected 5 5
Expiration Date Error 5 5
Component Missing 5 5
Difficult or Delayed Positioning 5 5
Crack 5 5
Misassembled 4 4
Device Damaged Prior to Use 4 4
Therapeutic or Diagnostic Output Failure 4 4
Activation, Positioning or Separation Problem 3 3
Difficult to Advance 3 3
Missing Information 3 3
Defective Component 3 3
Incomplete or Missing Packaging 3 3
Failure to Disconnect 3 3
Device Slipped 3 3
Entrapment of Device 3 3
Biofilm coating in Device 3 3
Bent 2 2
Collapse 2 2
Device Difficult to Setup or Prepare 2 2
Material Rupture 2 2
Failure to Align 2 2
Dull, Blunt 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 9483 9485
Pain 9445 9446
Test Result 3019 3019
Foreign Body Reaction 2950 2950
Unspecified Infection 2424 2425
Tissue Damage 2122 2122
Joint Dislocation 1740 1740
Osteolysis 1701 1701
Injury 1686 1686
Discomfort 1671 1671
Inadequate Osseointegration 1546 1547
No Information 1401 1401
Not Applicable 1371 1371
Limited Mobility Of The Implanted Joint 1206 1206
Hypersensitivity/Allergic reaction 1183 1183
Reaction 1104 1104
Inflammation 910 910
Bone Fracture(s) 887 887
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 875 875
Loss of Range of Motion 793 793
Metal Related Pathology 766 766
Distress 651 651
Host-Tissue Reaction 615 615
Necrosis 602 602
Edema 585 585
Ambulation Difficulties 555 555
No Patient Involvement 503 503
No Consequences Or Impact To Patient 428 428
No Known Impact Or Consequence To Patient 424 424
Weakness 420 420
Adhesion(s) 411 411
Insufficient Information 394 394
No Clinical Signs, Symptoms or Conditions 380 380
Failure of Implant 368 368
Swelling 367 367
Cyst(s) 310 310
Swelling/ Edema 309 309
Scar Tissue 266 266
Anxiety 263 263
Synovitis 256 256
Deformity/ Disfigurement 254 254
Local Reaction 243 243
Unspecified Tissue Injury 231 231
Fatigue 215 215
Fall 199 199
Hematoma 186 186
Ossification 177 177
Joint Laxity 173 173
Thrombosis 166 166
Muscular Rigidity 153 153
Pulmonary Embolism 141 141
Blood Loss 129 129
Joint Disorder 127 127
Hemorrhage/Bleeding 119 119
Osteopenia/ Osteoporosis 99 99
Depression 94 94
Erosion 79 79
Pocket Erosion 76 76
Fibrosis 70 70
Wound Dehiscence 69 69
Nerve Damage 66 66
Hip Fracture 66 66
Physical Asymmetry 66 66
Cardiac Arrest 60 60
Hypoesthesia 59 59
Fluid Discharge 56 56
Muscle/Tendon Damage 56 56
Death 56 56
Scarring 54 54
Impaired Healing 54 54
Toxicity 53 53
Abscess 51 51
Sepsis 49 49
Rash 49 49
Myocardial Infarction 48 48
Fever 47 47
Infarction, Cerebral 44 44
Post Operative Wound Infection 42 42
Stroke/CVA 39 39
Headache 38 38
Calcium Deposits/Calcification 37 37
Numbness 37 37
Memory Loss/Impairment 35 35
Bacterial Infection 34 34
Renal Failure 33 33
Hearing Impairment 32 32
Foreign Body In Patient 32 32
Limb Fracture 30 30
Tinnitus 30 30
Anemia 26 26
Dizziness 23 23
Burning Sensation 23 23
Heart Failure 22 22
Nausea 21 21
Neuropathy 20 20
Itching Sensation 20 20
Atrial Fibrillation 20 20
Dyspnea 20 20
Arthralgia 20 20
Thrombosis/Thrombus 19 19

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Aug-12-2021
2 DePuy Orthopaedics, Inc. II Jan-07-2021
3 Zimmer Biomet, Inc. II Nov-07-2019
4 Zimmer Biomet, Inc. II Dec-19-2018
5 Zimmer Biomet, Inc. II Aug-14-2018
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