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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device prosthesis, hip, semi-constrained, metal/polymer, uncemented
Product CodeLWJ
Regulation Number 888.3360
Device Class 2

MDR Year MDR Reports MDR Events
2019 211 211
2020 189 189
2021 155 155
2022 91 91
2023 72 72
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 135 135
Break 132 132
Insufficient Information 101 101
Device Dislodged or Dislocated 89 89
Fracture 57 57
Loose or Intermittent Connection 47 47
Loss of Osseointegration 28 28
Osseointegration Problem 26 26
Corroded 24 24
Detachment of Device or Device Component 13 13
Appropriate Term/Code Not Available 12 12
Migration 11 11
Material Integrity Problem 10 10
Mechanical Problem 10 10
Compatibility Problem 8 8
Difficult to Remove 8 8
Degraded 8 8
No Apparent Adverse Event 7 7
Naturally Worn 7 7
Material Fragmentation 7 7
Patient Device Interaction Problem 7 7
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Mechanical Jam 5 5
Use of Device Problem 5 5
Physical Resistance/Sticking 4 4
Biocompatibility 4 4
Malposition of Device 3 3
Packaging Problem 3 3
Device Difficult to Setup or Prepare 3 3
Material Disintegration 3 3
Migration or Expulsion of Device 3 3
Device Appears to Trigger Rejection 3 3
Unstable 3 3
Device Fell 2 2
Tear, Rip or Hole in Device Packaging 2 2
Patient-Device Incompatibility 2 2
Failure to Osseointegrate 2 2
Noise, Audible 2 2
Scratched Material 2 2
Entrapment of Device 2 2
Failure to Disconnect 1 1
Difficult to Insert 1 1
Positioning Problem 1 1
Material Erosion 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Collapse 1 1
Output Problem 1 1
Defective Device 1 1
Material Deformation 1 1
Device-Device Incompatibility 1 1
Inadequacy of Device Shape and/or Size 1 1
Fitting Problem 1 1
Component Incompatible 1 1
Component or Accessory Incompatibility 1 1
Separation Failure 1 1
Off-Label Use 1 1
Expulsion 1 1
Positioning Failure 1 1
Expiration Date Error 1 1
Problem with Sterilization 1 1
Measurement System Incompatibility 1 1
Product Quality Problem 1 1
Material Discolored 1 1
Improper or Incorrect Procedure or Method 1 1
Unexpected Therapeutic Results 1 1
Connection Problem 1 1
Delivered as Unsterile Product 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 185 185
Pain 87 87
Insufficient Information 73 73
Unspecified Infection 63 63
Bone Fracture(s) 59 59
Failure of Implant 56 56
No Clinical Signs, Symptoms or Conditions 51 51
No Code Available 39 39
Inadequate Osseointegration 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Joint Dislocation 24 24
Metal Related Pathology 20 20
Injury 17 17
Patient Problem/Medical Problem 15 15
Foreign Body Reaction 15 15
Loss of Range of Motion 13 13
Fall 13 13
Osteolysis 13 13
No Known Impact Or Consequence To Patient 11 11
Limb Fracture 11 11
Joint Laxity 11 11
Joint Disorder 9 9
Hip Fracture 9 9
Hypersensitivity/Allergic reaction 9 9
Discomfort 7 7
Foreign Body In Patient 7 7
Reaction 6 6
Inflammation 6 6
Unequal Limb Length 6 6
Bacterial Infection 5 5
Ambulation Difficulties 5 5
Necrosis 5 5
Test Result 4 4
Wound Dehiscence 4 4
Death 4 4
No Consequences Or Impact To Patient 4 4
Unspecified Tissue Injury 4 4
Swelling/ Edema 4 4
Swelling 3 3
Synovitis 3 3
Tissue Damage 3 3
Fatigue 3 3
Ossification 3 3
Fever 2 2
Dyspnea 2 2
Edema 2 2
Hemorrhage/Bleeding 2 2
Limited Mobility Of The Implanted Joint 2 2
Device Embedded In Tissue or Plaque 2 2
Fibrosis 2 2
Distress 2 2
Toxicity 2 2
Blood Loss 2 2
Shaking/Tremors 2 2
Implant Pain 2 2
Thrombosis/Thrombus 2 2
Subluxation 1 1
Reaction to Medicinal Component of Device 1 1
Muscle/Tendon Damage 1 1
Sleep Dysfunction 1 1
No Patient Involvement 1 1
Numbness 1 1
Impaired Healing 1 1
Arthralgia 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Not Applicable 1 1
Paresthesia 1 1
Patch Test, Abnormal Results Of 1 1
Tissue Breakdown 1 1
Osteopenia/ Osteoporosis 1 1
Vascular Dissection 1 1
Keratitis 1 1
Memory Loss/Impairment 1 1
Muscular Rigidity 1 1
Anxiety 1 1
Rash 1 1
Sepsis 1 1
Skin Irritation 1 1
Encephalopathy 1 1
Purulent Discharge 1 1
Hematoma 1 1
Adhesion(s) 1 1
Anemia 1 1
Arrhythmia 1 1
Host-Tissue Reaction 1 1
Erosion 1 1
Cyst(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Jan-31-2024
2 MicroPort Orthopedics Inc. I Sep-18-2020
3 MicroPort Orthopedics Inc. II Sep-09-2020
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