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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
2018 430 430
2019 971 971
2020 373 373
2021 17 17
2022 13 13
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 690 690
Insufficient Information 228 228
Device Dislodged or Dislocated 207 207
Migration 153 153
Naturally Worn 141 141
Loss of Osseointegration 123 123
Appropriate Term/Code Not Available 88 88
Corroded 76 76
Fracture 54 54
Loss of or Failure to Bond 45 45
Osseointegration Problem 45 45
Degraded 44 44
Noise, Audible 39 39
Biocompatibility 26 26
Use of Device Problem 24 24
Nonstandard Device 23 23
Loose or Intermittent Connection 18 18
Material Erosion 18 18
Malposition of Device 17 17
Unintended Movement 17 17
Inadequacy of Device Shape and/or Size 13 13
Break 12 12
Material Disintegration 11 11
Metal Shedding Debris 10 10
Failure to Osseointegrate 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Off-Label Use 4 4
Patient-Device Incompatibility 3 3
Migration or Expulsion of Device 3 3
Device-Device Incompatibility 2 2
Expiration Date Error 2 2
Particulates 2 2
Entrapment of Device 2 2
Physical Resistance/Sticking 2 2
No Apparent Adverse Event 2 2
Material Integrity Problem 2 2
Output Problem 2 2
Packaging Problem 2 2
Illegible Information 2 2
Scratched Material 1 1
Mechanical Jam 1 1
Difficult or Delayed Separation 1 1
Patient Device Interaction Problem 1 1
Device Expiration Issue 1 1
Material Separation 1 1
Incorrect Measurement 1 1
Mechanical Problem 1 1
Difficult to Insert 1 1
Unstable 1 1
Microbial Contamination of Device 1 1
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 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 1097 1097
Pain 843 843
Foreign Body Reaction 281 281
Test Result 259 259
Unspecified Infection 256 256
Joint Dislocation 205 205
Not Applicable 174 174
Tissue Damage 163 163
Bone Fracture(s) 150 150
No Consequences Or Impact To Patient 144 144
Osteolysis 133 133
Inadequate Osseointegration 123 123
Hypersensitivity/Allergic reaction 112 112
Injury 97 97
Limited Mobility Of The Implanted Joint 80 80
No Patient Involvement 68 68
Reaction 51 51
Discomfort 47 47
Thrombosis 45 45
Edema 39 39
Loss of Range of Motion 38 38
Inflammation 35 35
Pulmonary Embolism 31 31
No Information 25 25
Metal Related Pathology 24 24
Necrosis 23 23
Adhesion(s) 21 21
Hematoma 20 20
Weakness 17 17
Host-Tissue Reaction 16 16
Ossification 16 16
Sepsis 15 15
Hemorrhage/Bleeding 14 14
Toxicity 14 14
Swelling 13 13
Fatigue 12 12
Ambulation Difficulties 12 12
Distress 11 11
Cyst(s) 11 11
Myocardial Infarction 11 11
Nerve Damage 10 10
Joint Disorder 10 10
Anxiety 9 9
Stroke/CVA 9 9
Death 8 8
Pocket Erosion 8 8
No Known Impact Or Consequence To Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Memory Loss/Impairment 7 7
Muscular Rigidity 6 6
Pneumonia 6 6
Failure of Implant 6 6
Neuropathy 6 6
Synovitis 6 6
Fall 6 6
Post Operative Wound Infection 6 6
Hip Fracture 5 5
Hypoesthesia 5 5
Deformity/ Disfigurement 5 5
Insufficient Information 5 5
Local Reaction 5 5
Renal Failure 5 5
Tinnitus 4 4
Hearing Impairment 4 4
Wound Dehiscence 4 4
Depression 4 4
Heart Failure 3 3
Respiratory Failure 3 3
Fibrosis 3 3
Osteopenia/ Osteoporosis 3 3
Unspecified Tissue Injury 3 3
Swelling/ Edema 3 3
Erosion 3 3
Urinary Retention 3 3
Skin Irritation 3 3
Scarring 3 3
Tachycardia 2 2
Scar Tissue 2 2
Rash 2 2
Neurological Deficit/Dysfunction 2 2
Cardiac Arrest 2 2
Arthritis 2 2
Dyspnea 2 2
Hair Loss 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Thromboembolism 2 2
Foreign Body In Patient 2 2
Irritability 2 2
Pressure Sores 2 2
Impaired Healing 2 2
Numbness 1 1
Respiratory Tract Infection 1 1
Arthralgia 1 1
Shaking/Tremors 1 1
Confusion/ Disorientation 1 1
Blood Loss 1 1
Weight Changes 1 1
Decreased Sensitivity 1 1
Fluid Discharge 1 1
Muscle/Tendon Damage 1 1

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