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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/polymer, uncemented
Product CodeLWJ
Regulation Number 888.3360
Device Class 2

MDR Year MDR Reports MDR Events
2018 227 227
2019 211 211
2020 189 189
2021 158 158
2022 95 95
2023 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Break 197 197
Adverse Event Without Identified Device or Use Problem 143 143
Insufficient Information 140 140
Device Dislodged or Dislocated 109 109
Fracture 76 76
Loose or Intermittent Connection 55 55
Loss of Osseointegration 36 36
Corroded 34 34
Osseointegration Problem 29 29
Appropriate Term/Code Not Available 17 17
Material Integrity Problem 16 16
Detachment of Device or Device Component 13 13
Naturally Worn 13 13
Migration 11 11
Mechanical Problem 11 11
Degraded 10 10
Material Fragmentation 8 8
Difficult to Remove 8 8
No Apparent Adverse Event 8 8
Compatibility Problem 8 8
Patient Device Interaction Problem 7 7
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Mechanical Jam 6 6
Unstable 6 6
Use of Device Problem 5 5
Malposition of Device 5 5
Physical Resistance/Sticking 5 5
Biocompatibility 4 4
Device Difficult to Setup or Prepare 4 4
Device Appears to Trigger Rejection 4 4
Migration or Expulsion of Device 4 4
Material Discolored 3 3
Material Disintegration 3 3
Metal Shedding Debris 3 3
Patient-Device Incompatibility 3 3
Packaging Problem 3 3
Positioning Problem 2 2
Scratched Material 2 2
Noise, Audible 2 2
Device Fell 2 2
Failure to Osseointegrate 2 2
Tear, Rip or Hole in Device Packaging 2 2
Entrapment of Device 2 2
Material Erosion 1 1
Positioning Failure 1 1
Disassembly 1 1
Delivered as Unsterile Product 1 1
Difficult to Insert 1 1
Collapse 1 1
Component Incompatible 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Defective Device 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequacy of Device Shape and/or Size 1 1
Problem with Sterilization 1 1
Unexpected Therapeutic Results 1 1
Unintended Movement 1 1
Component or Accessory Incompatibility 1 1
Device-Device Incompatibility 1 1
Expulsion 1 1
Mechanics Altered 1 1
Output Problem 1 1
Material Deformation 1 1
Measurement System Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 289 289
Pain 125 125
Unspecified Infection 76 76
Bone Fracture(s) 73 73
Insufficient Information 60 60
No Code Available 55 55
Failure of Implant 51 51
Inadequate Osseointegration 47 47
No Clinical Signs, Symptoms or Conditions 47 47
Injury 30 30
Joint Dislocation 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
No Known Impact Or Consequence To Patient 21 21
Patient Problem/Medical Problem 18 18
Metal Related Pathology 18 18
Hip Fracture 18 18
Foreign Body Reaction 16 16
Osteolysis 14 14
Reaction 14 14
Loss of Range of Motion 14 14
Fall 12 12
Joint Laxity 12 12
Limb Fracture 10 10
Not Applicable 10 10
Hypersensitivity/Allergic reaction 10 10
Inflammation 10 10
Discomfort 10 10
Joint Disorder 9 9
Foreign Body In Patient 8 8
Ambulation Difficulties 8 8
Test Result 7 7
Unequal Limb Length 6 6
Limited Mobility Of The Implanted Joint 6 6
No Consequences Or Impact To Patient 6 6
Death 6 6
Tissue Damage 5 5
Necrosis 5 5
Synovitis 4 4
Wound Dehiscence 4 4
Bacterial Infection 4 4
Fatigue 4 4
Unspecified Tissue Injury 4 4
Swelling/ Edema 4 4
Device Embedded In Tissue or Plaque 3 3
Subluxation 3 3
Hemorrhage/Bleeding 3 3
Ossification 3 3
Edema 3 3
Swelling 3 3
Rash 3 3
Distress 3 3
Blood Loss 3 3
Shaking/Tremors 2 2
Anxiety 2 2
Toxicity 2 2
Cyst(s) 2 2
Dyspnea 2 2
Fever 2 2
Thrombosis/Thrombus 2 2
Fibrosis 2 2
Implant Pain 2 2
Reaction to Medicinal Component of Device 1 1
Patch Test, Abnormal Results Of 1 1
Vascular Dissection 1 1
Paresthesia 1 1
Muscle/Tendon Damage 1 1
Hair Loss 1 1
Head Injury 1 1
Hematoma 1 1
Keratitis 1 1
Memory Loss/Impairment 1 1
Muscular Rigidity 1 1
Infiltration into Tissue 1 1
Encephalopathy 1 1
Host-Tissue Reaction 1 1
Purulent Discharge 1 1
Adhesion(s) 1 1
Anemia 1 1
Arrhythmia 1 1
Arthritis 1 1
Autoimmune Disorder 1 1
Erosion 1 1
Cardiac Arrest 1 1
Infarction, Cerebral 1 1
Weakness 1 1
Rupture 1 1
Scarring 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Thyroid Problems 1 1
Skin Tears 1 1
Sleep Dysfunction 1 1
No Patient Involvement 1 1
Tissue Breakdown 1 1
Osteopenia/ Osteoporosis 1 1
Numbness 1 1
Impaired Healing 1 1
Depression 1 1
Non-union Bone Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MicroPort Orthopedics Inc. I Sep-18-2020
2 MicroPort Orthopedics Inc. II Sep-09-2020
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