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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/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
Product CodeMAY
Regulation Number 888.3353
Device Class 2

MDR Year MDR Reports MDR Events
2017 33 33
2018 33 33
2019 11 11
2020 14 14
2021 24 24
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 32 32
Insufficient Information 17 17
Device Dislodged or Dislocated 16 16
Adverse Event Without Identified Device or Use Problem 16 16
Break 8 8
Appropriate Term/Code Not Available 7 7
Tear, Rip or Hole in Device Packaging 5 5
Device Contaminated During Manufacture or Shipping 5 5
Migration 4 4
Naturally Worn 4 4
Material Fragmentation 4 4
Unstable 4 4
Migration or Expulsion of Device 3 3
Detachment of Device or Device Component 3 3
Device-Device Incompatibility 2 2
Packaging Problem 2 2
Noise, Audible 2 2
Metal Shedding Debris 2 2
Loss of or Failure to Bond 2 2
Mechanical Problem 2 2
Difficult to Insert 2 2
Loose or Intermittent Connection 1 1
Detachment Of Device Component 1 1
Crack 1 1
Degraded 1 1
Disassembly 1 1
Improper or Incorrect Procedure or Method 1 1
Difficult To Position 1 1
Inadequacy of Device Shape and/or Size 1 1
Unraveled Material 1 1
Material Too Soft/Flexible 1 1
Physical Resistance/Sticking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Joint Dislocation 22 22
Pain 20 20
No Information 19 19
Unspecified Infection 16 16
No Clinical Signs, Symptoms or Conditions 14 14
No Patient Involvement 11 11
Failure of Implant 11 11
No Code Available 7 7
Bone Fracture(s) 7 7
No Known Impact Or Consequence To Patient 6 6
Swelling 4 4
Scar Tissue 3 3
Swelling/ Edema 3 3
Insufficient Information 2 2
Osteopenia/ Osteoporosis 2 2
No Consequences Or Impact To Patient 2 2
Reaction 2 2
Numbness 2 2
Malunion of Bone 2 2
Unequal Limb Length 2 2
Hip Fracture 2 2
Ambulation Difficulties 2 2
Blood Loss 2 2
Sleep Dysfunction 1 1
Hypovolemia 1 1
Toxicity 1 1
Sepsis 1 1
Synovitis 1 1
Tinnitus 1 1
Tissue Damage 1 1
Memory Loss/Impairment 1 1
Necrosis 1 1
Local Reaction 1 1
Headache 1 1
Hearing Loss 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Arthritis 1 1
Atrial Fibrillation 1 1
Emotional Changes 1 1
Fall 1 1
Limited Mobility Of The Implanted Joint 1 1

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