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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, femoral, resurfacing
Product CodeKXA
Regulation Number 888.3400
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOCORE9 LLC
  SUBSTANTIALLY EQUIVALENT 1
CORIN USA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 2438 2438
2015 1684 1684
2016 625 625
2017 580 580
2018 430 430
2019 971 971
2020 373 373
2021 17 17
2022 13 13
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4090 4090
Adverse Event Without Identified Device or Use Problem 902 902
Appropriate Term/Code Not Available 549 549
Device Dislodged or Dislocated 411 411
Loss of Osseointegration 403 403
Noise, Audible 335 335
Metal Shedding Debris 256 256
Naturally Worn 205 205
Migration 153 153
Corroded 152 152
Fracture 99 99
Loss of or Failure to Bond 71 71
Malposition of Device 56 56
Osseointegration Problem 53 53
Degraded 52 52
Loose or Intermittent Connection 45 45
Nonstandard Device 45 45
Use of Device Problem 27 27
Migration or Expulsion of Device 26 26
Biocompatibility 26 26
Device Slipped 24 24
Material Erosion 23 23
Break 21 21
Unintended Movement 17 17
Material Disintegration 17 17
Inadequacy of Device Shape and/or Size 14 14
Patient-Device Incompatibility 12 12
Device Operates Differently Than Expected 11 11
Failure to Osseointegrate 9 9
Unstable 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Mechanical Problem 6 6
Patient Device Interaction Problem 4 4
Off-Label Use 4 4
Product Quality Problem 4 4
Material Integrity Problem 3 3
Disassembly 3 3
Particulates 3 3
Device Issue 3 3
Material Separation 2 2
Physical Resistance/Sticking 2 2
Detachment Of Device Component 2 2
Device-Device Incompatibility 2 2
Output Problem 2 2
Packaging Problem 2 2
Entrapment of Device 2 2
Difficult to Insert 2 2
No Apparent Adverse Event 2 2
Connection Problem 2 2
Failure To Adhere Or Bond 2 2
Illegible Information 2 2
Expiration Date Error 2 2
Bent 1 1
Tear, Rip or Hole in Device Packaging 1 1
Explanted 1 1
Component Missing 1 1
Activation, Positioning or Separation Problem 1 1
Incorrect Measurement 1 1
Difficult or Delayed Separation 1 1
Device Markings/Labelling Problem 1 1
Scratched Material 1 1
Ambient Noise Problem 1 1
Microbial Contamination of Device 1 1
Torn Material 1 1
Crack 1 1
Device Expiration Issue 1 1
Incorrect Device Or Component Shipped 1 1
Device Contamination with Chemical or Other Material 1 1
Decrease in Pressure 1 1
Device Contaminated During Manufacture or Shipping 1 1
Incomplete or Missing Packaging 1 1
Excess Flow or Over-Infusion 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 3925 3925
No Code Available 2357 2357
Host-Tissue Reaction 1440 1440
No Information 1200 1200
Foreign Body Reaction 779 779
Tissue Damage 477 477
Unspecified Infection 353 353
Osteolysis 347 347
Discomfort 318 318
Test Result 282 282
Bone Fracture(s) 257 257
Joint Dislocation 234 234
Not Applicable 228 228
Injury 156 156
No Consequences Or Impact To Patient 150 150
Inflammation 141 141
Inadequate Osseointegration 139 139
Limited Mobility Of The Implanted Joint 136 136
Reaction 135 135
Hypersensitivity/Allergic reaction 121 121
Necrosis 81 81
Loss of Range of Motion 76 76
Ambulation Difficulties 74 74
Toxicity 69 69
No Patient Involvement 68 68
Weakness 58 58
Muscle Weakness 57 57
Edema 55 55
Swelling 53 53
Thrombosis 46 46
Joint Swelling 35 35
Failure of Implant 34 34
Pulmonary Embolism 34 34
Cyst(s) 33 33
Death 30 30
Synovitis 28 28
Metal Related Pathology 27 27
Adhesion(s) 25 25
No Known Impact Or Consequence To Patient 24 24
Ossification 21 21
Hematoma 20 20
Fall 18 18
Joint Disorder 18 18
Distress 16 16
Hip Fracture 16 16
Fatigue 16 16
Hemorrhage/Bleeding 15 15
Sepsis 15 15
Deformity/ Disfigurement 15 15
Anxiety 15 15
Scar Tissue 14 14
Disability 13 13
Malaise 13 13
Muscular Rigidity 12 12
Myocardial Infarction 11 11
Stroke/CVA 11 11
Nerve Damage 10 10
Memory Loss/Impairment 9 9
Complaint, Ill-Defined 9 9
Pocket Erosion 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Scarring 8 8
Wound Dehiscence 7 7
Tinnitus 7 7
Depression 6 6
Fibrosis 6 6
Post Operative Wound Infection 6 6
Skin Irritation 6 6
Neuropathy 6 6
Pneumonia 6 6
Local Reaction 6 6
Irritation 6 6
Renal Failure 5 5
Hearing Impairment 5 5
Osteopenia/ Osteoporosis 5 5
Hypoesthesia 5 5
Swelling/ Edema 5 5
Insufficient Information 5 5
Unspecified Tissue Injury 4 4
Foreign Body In Patient 4 4
Headache 4 4
Erosion 4 4
Arthritis 4 4
Rash 4 4
Damage to Ligament(s) 3 3
Hair Loss 3 3
Embolus 3 3
Fluid Discharge 3 3
Confusion/ Disorientation 3 3
Respiratory Failure 3 3
Inadequate Pain Relief 3 3
Urinary Retention 3 3
Heart Failure 3 3
Pressure Sores 2 2
Cramp(s) 2 2
Impaired Healing 2 2
Shaking/Tremors 2 2
Irritability 2 2
Numbness 2 2
Claudication 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Depuy Orthopaedics, Inc. II Mar-24-2011
2 Zimmer, Inc. II Nov-06-2012
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