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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
2015 311 311
2016 296 296
2017 311 311
2018 227 227
2019 211 211
2020 141 141

Device Problems MDRs with this Device Problem Events in those MDRs
Break 366 366
Insufficient Information 351 351
Device Dislodged or Dislocated 153 153
Fracture 139 139
Loose or Intermittent Connection 83 83
Corroded 72 72
Adverse Event Without Identified Device or Use Problem 61 61
Loss of Osseointegration 57 57
Appropriate Term/Code Not Available 40 40
Metal Shedding Debris 37 37
Dull, Blunt 36 36
Naturally Worn 35 35
Migration or Expulsion of Device 24 24
Material Integrity Problem 17 17
Unstable 15 15
Difficult to Remove 12 12
Device Operates Differently Than Expected 11 11
Compatibility Problem 10 10
Osseointegration Problem 9 9
Handpiece 9 9
Device Slipped 9 9
Noise, Audible 8 8
Malposition of Device 8 8
Material Discolored 8 8
Patient Device Interaction Problem 6 6
Material Fragmentation 6 6
Degraded 6 6
Patient-Device Incompatibility 5 5
Thread 5 5
Failure To Adhere Or Bond 5 5
Detachment Of Device Component 5 5
Inadequacy of Device Shape and/or Size 5 5
Fitting Problem 4 4
Migration 4 4
Material Deformation 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Device Difficult to Setup or Prepare 4 4
Material Disintegration 4 4
Disassembly 3 3
Mechanical Problem 3 3
Screw 3 3
Component Missing 3 3
Use of Device Problem 3 3
Positioning Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Physical Resistance/Sticking 2 2
Scratched Material 2 2
Entrapment of Device 2 2
Material Separation 2 2
Mechanical Jam 2 2
Collapse 2 2
Component Incompatible 2 2
Crack 2 2
Loss of or Failure to Bond 2 2
Device Expiration Issue 1 1
Nonstandard Device 1 1
Cup 1 1
Positioning Failure 1 1
Device Damaged by Another Device 1 1
Component or Accessory Incompatibility 1 1
Detachment of Device or Device Component 1 1
Problem with Sterilization 1 1
Material Too Rigid or Stiff 1 1
Device Issue 1 1
Failure to Align 1 1
No Apparent Adverse Event 1 1
Packaging Problem 1 1
Material Erosion 1 1
Difficult to Insert 1 1
Shaft 1 1
Biofilm coating in Device 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Appears to Trigger Rejection 1 1
Connection Problem 1 1
Device Subassembly 1 1
Material Distortion 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 551 551
Pain 256 256
No Code Available 175 175
Unspecified Infection 126 126
No Known Impact Or Consequence To Patient 99 99
Bone Fracture(s) 98 98
Reaction 76 76
Injury 60 60
No Consequences Or Impact To Patient 47 47
Joint Dislocation 41 41
Toxicity 29 29
Inadequate Osseointegration 27 27
Ambulation Difficulties 25 25
Fall 18 18
Patient Problem/Medical Problem 18 18
Test Result 18 18
Osteolysis 16 16
Inflammation 15 15
Limited Mobility Of The Implanted Joint 15 15
Tissue Damage 14 14
Failure of Implant 13 13
Swelling 12 12
Hip Fracture 12 12
Complaint, Ill-Defined 12 12
Joint Disorder 10 10
Not Applicable 10 10
Foreign Body In Patient 9 9
Death 9 9
Necrosis 8 8
Discomfort 8 8
Loss of Range of Motion 7 7
Host-Tissue Reaction 7 7
Hematoma 6 6
Fluid Discharge 6 6
Fatigue 5 5
Rash 5 5
Synovitis 5 5
Missing Value Reason 5 5
No Patient Involvement 4 4
Ossification 4 4
Scar Tissue 3 3
Foreign Body Reaction 3 3
Blood Loss 3 3
Sepsis 3 3
Sleep Dysfunction 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Skin Discoloration 2 2
Infiltration into Tissue 2 2
Numbness 2 2
Hypersensitivity/Allergic reaction 2 2
Arthritis 2 2
Aspiration/Inhalation 2 2
Device Embedded In Tissue or Plaque 2 2
Fibrosis 2 2
Weakness 2 2
Shaking/Tremors 2 2
Muscular Rigidity 2 2
Purulent Discharge 2 2
Edema 2 2
Hair Loss 1 1
Hemorrhage/Bleeding 1 1
Adhesion(s) 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Cellulitis 1 1
Infarction, Cerebral 1 1
Nerve Damage 1 1
Scarring 1 1
Pneumonia 1 1
Chemical Exposure 1 1
Arthralgia 1 1
Joint Swelling 1 1
Non-union Bone Fracture 1 1
Burning Sensation 1 1
Anxiety 1 1
Distress 1 1
Thyroid Problems 1 1
Patch Test, Abnormal Results Of 1 1
Weight Changes 1 1
Autoimmune Disorder 1 1
Erosion 1 1
Cyst(s) 1 1
Dyspnea 1 1
Encephalopathy 1 1
Fever 1 1
Memory Loss/Impairment 1 1
Muscle Weakness 1 1
Paresis 1 1
Skin Tears 1 1
Deformity/ Disfigurement 1 1
Rupture 1 1
Cramp(s) 1 1
Skin Irritation 1 1
Spinal Column Injury 1 1
Vascular Dissection 1 1
Multiple Organ Failure 1 1
Cancer 1 1
Pericardial Effusion 1 1
Metal Related Pathology 1 1
Reaction to Medicinal Component of Device 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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