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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
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeLWJ
Regulation Number 888.3360
Device Class 2

MDR Year MDR Reports MDR Events
2016 297 297
2017 312 312
2018 226 226
2019 211 211
2020 184 184
2021 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Break 345 345
Insufficient Information 299 299
Device Dislodged or Dislocated 138 138
Fracture 90 90
Loose or Intermittent Connection 73 73
Adverse Event Without Identified Device or Use Problem 60 60
Corroded 50 50
Loss of Osseointegration 41 41
Dull, Blunt 36 36
Appropriate Term/Code Not Available 20 20
Material Integrity Problem 19 19
Osseointegration Problem 17 17
Naturally Worn 16 16
Migration or Expulsion of Device 15 15
Metal Shedding Debris 11 11
Difficult to Remove 10 10
Compatibility Problem 10 10
Unstable 10 10
Malposition of Device 7 7
Patient Device Interaction Problem 7 7
Material Fragmentation 6 6
Migration 6 6
Mechanical Problem 5 5
Device Difficult to Setup or Prepare 4 4
Degraded 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Patient-Device Incompatibility 4 4
Material Discolored 4 4
Failure To Adhere Or Bond 4 4
Detachment Of Device Component 3 3
Material Deformation 3 3
Component Missing 3 3
Mechanical Jam 3 3
Device Operates Differently Than Expected 3 3
Noise, Audible 3 3
Disassembly 3 3
Material Disintegration 3 3
Component Incompatible 2 2
Loss of or Failure to Bond 2 2
Packaging Problem 2 2
Use of Device Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Scratched Material 2 2
Physical Resistance/Sticking 2 2
Fitting Problem 2 2
Biocompatibility 2 2
Entrapment of Device 2 2
Material Erosion 1 1
Difficult to Insert 1 1
Biofilm coating in Device 1 1
Device Appears to Trigger Rejection 1 1
Connection Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Positioning Problem 1 1
Material Distortion 1 1
Mechanics Altered 1 1
Device Damaged by Another Device 1 1
Device Issue 1 1
Component or Accessory Incompatibility 1 1
Detachment of Device or Device Component 1 1
Problem with Sterilization 1 1
Nonstandard Device 1 1
Crack 1 1
Collapse 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 529 529
Pain 165 165
Unspecified Infection 109 109
No Known Impact Or Consequence To Patient 89 89
No Code Available 88 88
Reaction 66 66
Bone Fracture(s) 65 65
Injury 53 53
No Consequences Or Impact To Patient 47 47
Joint Dislocation 37 37
Inadequate Osseointegration 35 35
Failure of Implant 20 20
Patient Problem/Medical Problem 18 18
Hip Fracture 14 14
Inflammation 12 12
Fall 10 10
Osteolysis 10 10
Insufficient Information 10 10
Not Applicable 10 10
Joint Disorder 9 9
Death 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Metal Related Pathology 7 7
Loss of Range of Motion 7 7
Discomfort 7 7
Foreign Body In Patient 7 7
Limited Mobility Of The Implanted Joint 6 6
Tissue Damage 6 6
Ambulation Difficulties 6 6
Swelling 5 5
Rash 5 5
Fatigue 5 5
Test Result 5 5
Missing Value Reason 5 5
No Patient Involvement 4 4
Host-Tissue Reaction 4 4
Hypersensitivity/Allergic reaction 3 3
Toxicity 3 3
Sleep Dysfunction 3 3
Fluid Discharge 3 3
Unequal Limb Length 3 3
Blood Loss 3 3
Necrosis 3 3
Edema 3 3
Foreign Body Reaction 3 3
Ossification 3 3
Weakness 2 2
Shaking/Tremors 2 2
Device Embedded In Tissue or Plaque 2 2
Limb Fracture 2 2
Hematoma 2 2
Infiltration into Tissue 2 2
Memory Loss/Impairment 1 1
Paresis 1 1
Sepsis 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Spinal Column Injury 1 1
Wound Dehiscence 1 1
Arthritis 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Cyst(s) 1 1
Dyspnea 1 1
Encephalopathy 1 1
Reaction to Medicinal Component of Device 1 1
Vascular Dissection 1 1
Pericardial Effusion 1 1
Thrombosis/Thrombus 1 1
Skin Tears 1 1
Rupture 1 1
Joint Laxity 1 1
Patch Test, Abnormal Results Of 1 1
Fibrosis 1 1
Weight Changes 1 1
Nerve Damage 1 1
Arthralgia 1 1
Non-union Bone Fracture 1 1
Burning Sensation 1 1
Anxiety 1 1
Distress 1 1
Scar Tissue 1 1
Scarring 1 1
Synovitis 1 1
Thyroid Problems 1 1
Adhesion(s) 1 1
Cardiac Arrest 1 1
Infarction, Cerebral 1 1
Hair Loss 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MicroPort Orthopedics Inc. I Sep-18-2020
2 MicroPort Orthopedics Inc. II Sep-09-2020
3 MicroPort Orthopedics Inc. II Aug-18-2016
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