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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 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Break 141 141
Adverse Event Without Identified Device or Use Problem 140 140
Insufficient Information 109 109
Device Dislodged or Dislocated 91 91
Fracture 58 58
Loose or Intermittent Connection 47 47
Loss of Osseointegration 28 28
Osseointegration Problem 26 26
Corroded 25 25
Detachment of Device or Device Component 13 13
Appropriate Term/Code Not Available 12 12
Mechanical Problem 11 11
Migration 11 11
Material Integrity Problem 10 10
Compatibility Problem 8 8
Naturally Worn 8 8
Difficult to Remove 8 8
Degraded 8 8
No Apparent Adverse Event 7 7
Material Fragmentation 7 7
Patient Device Interaction Problem 7 7
Use of Device Problem 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Biocompatibility 5 5
Mechanical Jam 5 5
Device Appears to Trigger Rejection 4 4
Physical Resistance/Sticking 4 4
Noise, Audible 3 3
Tear, Rip or Hole in Device Packaging 3 3
Packaging Problem 3 3
Failure to Osseointegrate 3 3
Device Difficult to Setup or Prepare 3 3
Patient-Device Incompatibility 3 3
Material Disintegration 3 3
Malposition of Device 3 3
Migration or Expulsion of Device 3 3
Unstable 3 3
Scratched Material 2 2
Delivered as Unsterile Product 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Fell 2 2
Entrapment of Device 2 2
Difficult to Insert 1 1
Positioning Failure 1 1
Material Discolored 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Positioning Problem 1 1
Problem with Sterilization 1 1
Measurement System Incompatibility 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 185 185
Pain 91 91
Insufficient Information 84 84
Unspecified Infection 66 66
Bone Fracture(s) 60 60
Failure of Implant 58 58
No Clinical Signs, Symptoms or Conditions 57 57
No Code Available 39 39
Inadequate Osseointegration 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Joint Dislocation 24 24
Metal Related Pathology 22 22
Injury 17 17
Patient Problem/Medical Problem 15 15
Foreign Body Reaction 15 15
Loss of Range of Motion 14 14
Osteolysis 13 13
Fall 13 13
Joint Laxity 12 12
No Known Impact Or Consequence To Patient 11 11
Limb Fracture 11 11
Hypersensitivity/Allergic reaction 9 9
Hip Fracture 9 9
Joint Disorder 9 9
Foreign Body In Patient 7 7
Discomfort 7 7
Unequal Limb Length 7 7
Inflammation 6 6
Reaction 6 6
Necrosis 5 5
Bacterial Infection 5 5
Ambulation Difficulties 5 5
Unspecified Tissue Injury 4 4
Test Result 4 4
Swelling/ Edema 4 4
No Consequences Or Impact To Patient 4 4
Death 4 4
Wound Dehiscence 4 4
Synovitis 3 3
Tissue Damage 3 3
Fatigue 3 3
Ossification 3 3
Swelling 3 3
Shaking/Tremors 2 2
Toxicity 2 2
Subluxation 2 2
Dyspnea 2 2
Hemorrhage/Bleeding 2 2
Fibrosis 2 2
Distress 2 2

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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