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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

MDR Year MDR Reports MDR Events
2017 580 580
2018 434 434
2019 971 971
2020 374 374
2021 17 17
2022 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 727 727
Insufficient Information 597 597
Device Dislodged or Dislocated 232 232
Appropriate Term/Code Not Available 211 211
Migration 153 153
Naturally Worn 149 149
Loss of Osseointegration 144 144
Corroded 88 88
Fracture 59 59
Noise, Audible 54 54
Osseointegration Problem 48 48
Loss of or Failure to Bond 48 48
Degraded 47 47
Loose or Intermittent Connection 25 25
Use of Device Problem 24 24
Metal Shedding Debris 24 24
Biocompatibility 24 24
Nonstandard Device 23 23
Material Erosion 18 18
Malposition of Device 18 18
Unintended Movement 17 17
Break 15 15
Inadequacy of Device Shape and/or Size 14 14
Migration or Expulsion of Device 13 13
Material Disintegration 12 12
Failure to Osseointegrate 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Patient-Device Incompatibility 5 5
Patient Device Interaction Problem 4 4
Off-Label Use 3 3
Device Slipped 2 2
Unstable 2 2
Expiration Date Error 2 2
Entrapment of Device 2 2
Mechanical Problem 2 2
Particulates 2 2
No Apparent Adverse Event 2 2
Device-Device Incompatibility 2 2
Material Integrity Problem 2 2
Output Problem 2 2
Packaging Problem 2 2
Illegible Information 2 2
Physical Resistance/Sticking 2 2
Difficult or Delayed Separation 1 1
Scratched Material 1 1
Mechanical Jam 1 1
Activation, Positioning or Separation Problem 1 1
Device Operates Differently Than Expected 1 1
Incorrect Measurement 1 1
Excess Flow or Over-Infusion 1 1
Difficult to Insert 1 1
Device Expiration Issue 1 1
Device Contamination with Chemical or Other Material 1 1
Incorrect Device Or Component Shipped 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Separation 1 1
Microbial Contamination of Device 1 1
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1200 1200
No Code Available 1195 1195
Foreign Body Reaction 363 363
Unspecified Infection 268 268
Test Result 263 263
Joint Dislocation 219 219
Tissue Damage 193 193
Not Applicable 182 182
Osteolysis 154 154
Bone Fracture(s) 154 154
No Consequences Or Impact To Patient 149 149
Host-Tissue Reaction 135 135
Inadequate Osseointegration 130 130
Hypersensitivity/Allergic reaction 119 119
Injury 113 113
No Information 99 99
Limited Mobility Of The Implanted Joint 95 95
Discomfort 89 89
Reaction 83 83
No Patient Involvement 68 68
Inflammation 57 57
Edema 46 46
Thrombosis 45 45
Loss of Range of Motion 43 43
Necrosis 35 35
Pulmonary Embolism 31 31
Weakness 31 31
Ambulation Difficulties 28 28
Failure of Implant 24 24
Metal Related Pathology 23 23
Swelling 20 20
Adhesion(s) 20 20
Hematoma 20 20
Toxicity 19 19
Distress 16 16
Ossification 16 16
Sepsis 15 15
Joint Disorder 15 15
Anxiety 15 15
No Known Impact Or Consequence To Patient 14 14
Cyst(s) 14 14
Hemorrhage/Bleeding 14 14
Fatigue 14 14
Myocardial Infarction 11 11
Nerve Damage 10 10
Hip Fracture 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Memory Loss/Impairment 9 9
Death 9 9
Stroke/CVA 9 9
Pocket Erosion 8 8
Synovitis 8 8
Muscular Rigidity 7 7
Neuropathy 6 6
Pneumonia 6 6
Fall 6 6
Local Reaction 6 6
Deformity/ Disfigurement 6 6
Post Operative Wound Infection 6 6
Depression 5 5
Hypoesthesia 5 5
Unspecified Tissue Injury 5 5
Fibrosis 5 5
Renal Failure 5 5
Skin Irritation 4 4
Wound Dehiscence 4 4
Hearing Impairment 4 4
Insufficient Information 4 4
Tinnitus 4 4
Heart Failure 3 3
Respiratory Failure 3 3
Swelling/ Edema 3 3
Foreign Body In Patient 3 3
Erosion 3 3
Urinary Retention 3 3
Scarring 3 3
Irritation 3 3
Neurological Deficit/Dysfunction 2 2
Rash 2 2
Tachycardia 2 2
Calcium Deposits/Calcification 2 2
Cardiac Arrest 2 2
Dyspnea 2 2
Arthritis 2 2
Hair Loss 2 2
Headache 2 2
Thromboembolism 2 2
Fluid Discharge 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Irritability 2 2
Impaired Healing 2 2
Pressure Sores 2 2
Joint Swelling 2 2
Malaise 2 2
Arthralgia 1 1
Cramp(s) 1 1
Thyroid Problems 1 1
Numbness 1 1
Respiratory Tract Infection 1 1
Sweating 1 1

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