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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
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
Adverse Event Without Identified Device or Use Problem 605 605
Device Dislodged or Dislocated 185 185
Migration 152 152
Naturally Worn 131 131
Loss of Osseointegration 112 112
Corroded 68 68
Fracture 47 47
Loss of or Failure to Bond 44 44
Degraded 43 43
Osseointegration Problem 43 43
Insufficient Information 31 31
Noise, Audible 25 25
Biocompatibility 25 25
Use of Device Problem 24 24
Nonstandard Device 23 23
Unintended Movement 17 17
Malposition of Device 15 15
Inadequacy of Device Shape and/or Size 11 11
Appropriate Term/Code Not Available 11 11
Break 9 9
Material Erosion 8 8
Loose or Intermittent Connection 7 7
Material Disintegration 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Failure to Osseointegrate 5 5
Off-Label Use 4 4
Migration or Expulsion of Device 3 3
Patient-Device Incompatibility 3 3
Material Integrity Problem 2 2
Expiration Date Error 2 2
Particulates 2 2
Entrapment of Device 2 2
Illegible Information 2 2
Physical Resistance/Sticking 2 2
Device-Device Incompatibility 2 2
Output Problem 2 2
Packaging Problem 1 1
Scratched Material 1 1
No Apparent Adverse Event 1 1
Difficult or Delayed Separation 1 1
Patient Device Interaction Problem 1 1
Difficult to Insert 1 1
Material Separation 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Unstable 1 1
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 1 1
Mechanical Jam 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 1023 1023
Pain 588 588
Foreign Body Reaction 257 257
Unspecified Infection 242 242
Test Result 225 225
Joint Dislocation 181 181
Bone Fracture(s) 140 140
No Consequences Or Impact To Patient 129 129
Osteolysis 112 112
Hypersensitivity/Allergic reaction 106 106
Inadequate Osseointegration 102 102
No Patient Involvement 68 68
Limited Mobility Of The Implanted Joint 61 61
Injury 56 56
Tissue Damage 52 52
Thrombosis 45 45
Not Applicable 38 38
Edema 37 37
Pulmonary Embolism 31 31
Discomfort 25 25
Loss of Range of Motion 24 24
Metal Related Pathology 24 24
Reaction 20 20
Necrosis 20 20
Hematoma 20 20
Inflammation 17 17
Adhesion(s) 17 17
Ossification 15 15
Sepsis 15 15
Hemorrhage/Bleeding 14 14
Myocardial Infarction 11 11
Fatigue 10 10
Weakness 10 10
No Information 10 10
Joint Disorder 9 9
Cyst(s) 9 9
Death 8 8
Stroke/CVA 8 8
Toxicity 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Ambulation Difficulties 7 7
Swelling 7 7
Nerve Damage 7 7
Memory Loss/Impairment 7 7
Failure of Implant 6 6
Neuropathy 6 6
Pneumonia 6 6
Anxiety 6 6
Post Operative Wound Infection 6 6
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 5 5
Pocket Erosion 5 5
Renal Failure 5 5
Tinnitus 4 4
Muscular Rigidity 4 4
Hearing Impairment 4 4
Fall 4 4
Wound Dehiscence 4 4
Depression 4 4
Local Reaction 3 3
Respiratory Failure 3 3
Osteopenia/ Osteoporosis 3 3
Unspecified Tissue Injury 3 3
Swelling/ Edema 3 3
Heart Failure 3 3
Hypoesthesia 3 3
Skin Irritation 3 3
Synovitis 2 2
Tachycardia 2 2
Scar Tissue 2 2
Neurological Deficit/Dysfunction 2 2
Hip Fracture 2 2
Distress 2 2
Pressure Sores 2 2
Dyspnea 2 2
Cardiac Arrest 2 2
Hair Loss 2 2
Thromboembolism 2 2
Foreign Body In Patient 2 2
Irritability 2 2
Deformity/ Disfigurement 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Numbness 1 1
Respiratory Tract Infection 1 1
Impaired Healing 1 1
Shaking/Tremors 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1
Weight Changes 1 1
Fibrosis 1 1
Decreased Sensitivity 1 1
Muscle/Tendon Damage 1 1
Limb Fracture 1 1
Malunion of Bone 1 1
Fever 1 1
Pyrosis/Heartburn 1 1
Hemorrhage, Subdural 1 1
Nausea 1 1
Ischemia 1 1
High Blood Pressure/ Hypertension 1 1

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