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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 188 188
2021 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Break 359 359
Insufficient Information 299 299
Device Dislodged or Dislocated 157 157
Fracture 97 97
Adverse Event Without Identified Device or Use Problem 85 85
Loose or Intermittent Connection 74 74
Loss of Osseointegration 59 59
Corroded 52 52
Dull, Blunt 36 36
Appropriate Term/Code Not Available 26 26
Osseointegration Problem 25 25
Material Integrity Problem 19 19
Naturally Worn 18 18
Migration or Expulsion of Device 15 15
Difficult to Remove 11 11
Migration 11 11
Metal Shedding Debris 11 11
Compatibility Problem 10 10
Unstable 10 10
Mechanical Problem 10 10
Degraded 8 8
Malposition of Device 7 7
Material Fragmentation 7 7
Patient Device Interaction Problem 7 7
Mechanical Jam 5 5
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Detachment of Device or Device Component 4 4
Device Difficult to Setup or Prepare 4 4
Use of Device Problem 4 4
Material Discolored 4 4
Failure To Adhere Or Bond 4 4
Patient-Device Incompatibility 4 4
Device Operates Differently Than Expected 3 3
Material Disintegration 3 3
Device Appears to Trigger Rejection 3 3
Disassembly 3 3
Component Missing 3 3
Noise, Audible 3 3
Biocompatibility 3 3
Scratched Material 3 3
Detachment Of Device Component 3 3
Material Deformation 3 3
Fitting Problem 3 3
Physical Resistance/Sticking 3 3
Device Contamination with Chemical or Other Material 2 2
Component Incompatible 2 2
Positioning Problem 2 2
Entrapment of Device 2 2
Material Erosion 2 2
Packaging Problem 2 2
Loss of or Failure to Bond 2 2
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 1 1
Problem with Sterilization 1 1
No Apparent Adverse Event 1 1
Biofilm coating in Device 1 1
Connection Problem 1 1
Nonstandard Device 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Collapse 1 1
Crack 1 1
Difficult to Insert 1 1
Material Distortion 1 1
Mechanics Altered 1 1
Positioning Failure 1 1
Device Issue 1 1
Component or Accessory Incompatibility 1 1
Device Damaged by Another Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 529 529
Pain 182 182
Unspecified Infection 118 118
No Code Available 90 90
No Known Impact Or Consequence To Patient 89 89
Bone Fracture(s) 75 75
Reaction 66 66
Injury 53 53
No Consequences Or Impact To Patient 47 47
Inadequate Osseointegration 43 43
Joint Dislocation 42 42
Failure of Implant 39 39
Insufficient Information 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
No Clinical Signs, Symptoms or Conditions 21 21
Patient Problem/Medical Problem 18 18
Osteolysis 14 14
Hip Fracture 14 14
Inflammation 14 14
Loss of Range of Motion 11 11
Foreign Body Reaction 11 11
Fall 11 11
Metal Related Pathology 11 11
Joint Laxity 10 10
Not Applicable 10 10
Death 9 9
Joint Disorder 9 9
Discomfort 9 9
Hypersensitivity/Allergic reaction 8 8
Limited Mobility Of The Implanted Joint 7 7
Ambulation Difficulties 7 7
Foreign Body In Patient 7 7
Test Result 7 7
Tissue Damage 6 6
Swelling 5 5
Fatigue 5 5
Rash 5 5
Unequal Limb Length 5 5
Missing Value Reason 5 5
Edema 4 4
Host-Tissue Reaction 4 4
Limb Fracture 4 4
No Patient Involvement 4 4
Ossification 3 3
Sleep Dysfunction 3 3
Toxicity 3 3
Blood Loss 3 3
Synovitis 3 3
Hemorrhage/Bleeding 3 3
Necrosis 3 3
Fluid Discharge 3 3
Hematoma 2 2
Device Embedded In Tissue or Plaque 2 2
Shaking/Tremors 2 2
Wound Dehiscence 2 2
Infiltration into Tissue 2 2
Adhesion(s) 2 2
Weakness 2 2
Fibrosis 2 2
Cyst(s) 2 2
Thrombosis/Thrombus 1 1
Reaction to Medicinal Component of Device 1 1
Paresis 1 1
Arthritis 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Arthralgia 1 1
Thyroid Problems 1 1
Unspecified Tissue Injury 1 1
Implant Pain 1 1
Burning Sensation 1 1
Anxiety 1 1
Hair Loss 1 1
Scar Tissue 1 1
Sepsis 1 1
Skin Discoloration 1 1
Spinal Column Injury 1 1
Anemia 1 1
Vascular Dissection 1 1
Pericardial Effusion 1 1
Encephalopathy 1 1
Memory Loss/Impairment 1 1
Skin Irritation 1 1
Rupture 1 1
Patch Test, Abnormal Results Of 1 1
Distress 1 1
Scarring 1 1
Nerve Damage 1 1
Cardiac Arrest 1 1
Head Injury 1 1
Dyspnea 1 1
Skin Tears 1 1
Non-union Bone Fracture 1 1
Weight Changes 1 1
Bacterial Infection 1 1
Infarction, Cerebral 1 1
Swelling/ Edema 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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