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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
2017 312 312
2018 226 226
2019 211 211
2020 189 189
2021 158 158
2022 64 64

Device Problems MDRs with this Device Problem Events in those MDRs
Break 266 266
Insufficient Information 241 241
Device Dislodged or Dislocated 148 148
Adverse Event Without Identified Device or Use Problem 101 101
Fracture 75 75
Loose or Intermittent Connection 67 67
Loss of Osseointegration 46 46
Corroded 41 41
Dull, Blunt 36 36
Osseointegration Problem 29 29
Appropriate Term/Code Not Available 21 21
Material Integrity Problem 16 16
Naturally Worn 13 13
Mechanical Problem 12 12
Migration or Expulsion of Device 11 11
Migration 11 11
Degraded 10 10
Metal Shedding Debris 9 9
Compatibility Problem 9 9
Detachment of Device or Device Component 9 9
Unstable 8 8
Difficult to Remove 7 7
Material Fragmentation 7 7
Patient Device Interaction Problem 7 7
No Apparent Adverse Event 7 7
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Mechanical Jam 6 6
Malposition of Device 6 6
Physical Resistance/Sticking 5 5
Patient-Device Incompatibility 4 4
Biocompatibility 4 4
Device Difficult to Setup or Prepare 4 4
Use of Device Problem 4 4
Device Appears to Trigger Rejection 4 4
Disassembly 3 3
Material Discolored 3 3
Material Disintegration 3 3
Material Deformation 3 3
Scratched Material 3 3
Packaging Problem 2 2
Positioning Problem 2 2
Device Fell 2 2
Noise, Audible 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Contamination with Chemical or Other Material 2 2
Entrapment of Device 2 2
Material Erosion 2 2
Collapse 1 1
Detachment Of Device Component 1 1
Component Incompatible 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Difficult to Insert 1 1
Positioning Failure 1 1
Loss of or Failure to Bond 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Inadequacy of Device Shape and/or Size 1 1
Problem with Sterilization 1 1
Unexpected Therapeutic Results 1 1
Failure to Osseointegrate 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Expiration Date Error 1 1
Separation Failure 1 1
Defective Device 1 1
Material Distortion 1 1
Measurement System Incompatibility 1 1
Component or Accessory Incompatibility 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Unintended Movement 1 1
Mechanics Altered 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 430 430
Pain 169 169
Unspecified Infection 107 107
No Code Available 62 62
Bone Fracture(s) 56 56
Insufficient Information 50 50
Inadequate Osseointegration 48 48
Failure of Implant 46 46
No Consequences Or Impact To Patient 44 44
Injury 44 44
No Clinical Signs, Symptoms or Conditions 40 40
Joint Dislocation 38 38
Reaction 38 38
No Known Impact Or Consequence To Patient 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Patient Problem/Medical Problem 18 18
Metal Related Pathology 16 16
Osteolysis 16 16
Foreign Body Reaction 15 15
Inflammation 14 14
Hip Fracture 13 13
Loss of Range of Motion 12 12
Discomfort 11 11
Joint Laxity 11 11
Not Applicable 10 10
Hypersensitivity/Allergic reaction 10 10
Fall 10 10
Joint Disorder 9 9
Ambulation Difficulties 8 8
Foreign Body In Patient 8 8
Limb Fracture 8 8
Test Result 7 7
Limited Mobility Of The Implanted Joint 7 7
Death 7 7
Tissue Damage 6 6
Unequal Limb Length 6 6
Rash 5 5
Fatigue 5 5
Necrosis 5 5
Host-Tissue Reaction 4 4
Swelling 4 4
Synovitis 4 4
No Patient Involvement 4 4
Swelling/ Edema 4 4
Unspecified Tissue Injury 3 3
Device Embedded In Tissue or Plaque 3 3
Blood Loss 3 3
Distress 3 3
Ossification 3 3
Edema 3 3
Wound Dehiscence 3 3
Hemorrhage/Bleeding 3 3
Dyspnea 2 2
Infiltration into Tissue 2 2
Cyst(s) 2 2
Fever 2 2
Toxicity 2 2
Weakness 2 2
Sleep Dysfunction 2 2
Fluid Discharge 2 2
Shaking/Tremors 2 2
Fibrosis 2 2
Patch Test, Abnormal Results Of 1 1
Vascular Dissection 1 1
Implant Pain 1 1
Reaction to Medicinal Component of Device 1 1
Paresthesia 1 1
Thrombosis/Thrombus 1 1
Subluxation 1 1
Skin Tears 1 1
Numbness 1 1
Non-union Bone Fracture 1 1
Impaired Healing 1 1
Tissue Breakdown 1 1
Weight Changes 1 1
Burning Sensation 1 1
Rupture 1 1
Anxiety 1 1
Thyroid Problems 1 1
Paresis 1 1
Scarring 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Spinal Column Injury 1 1
Encephalopathy 1 1
Purulent Discharge 1 1
Adhesion(s) 1 1
Anemia 1 1
Arrhythmia 1 1
Arthritis 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Infarction, Cerebral 1 1
Nerve Damage 1 1
Keratitis 1 1
Memory Loss/Impairment 1 1
Muscular Rigidity 1 1
Hair Loss 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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