• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, hip, femoral, resurfacing
Regulation Description Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
Product CodeKXA
Regulation Number 888.3400
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOCORE9 LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 373 373
2021 17 17
2022 13 13
2023 6 6
2024 2 2
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 169 169
Migration 79 79
Device Dislodged or Dislocated 41 41
Loss of Osseointegration 21 21
Naturally Worn 18 18
Insufficient Information 18 18
Corroded 13 13
Material Disintegration 9 9
Fracture 9 9
Noise, Audible 8 8
Biocompatibility 8 8
Loss of or Failure to Bond 8 8
Osseointegration Problem 7 7
Appropriate Term/Code Not Available 6 6
Material Erosion 6 6
Degraded 6 6
Malposition of Device 5 5
Unintended Movement 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Nonstandard Device 4 4
Inadequacy of Device Shape and/or Size 4 4
Use of Device Problem 4 4
Off-Label Use 4 4
Break 4 4
Patient-Device Incompatibility 3 3
Particulates 2 2
Material Integrity Problem 2 2
Illegible Information 2 2
Physical Resistance/Sticking 2 2
Output Problem 2 2
Migration or Expulsion of Device 2 2
Loose or Intermittent Connection 2 2
Entrapment of Device 2 2
Difficult to Insert 1 1
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Packaging Problem 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
No Apparent Adverse Event 1 1
Expiration Date Error 1 1
Mechanical Problem 1 1
Mechanical Jam 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device-Device Incompatibility 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 238 238
Pain 159 159
No Consequences Or Impact To Patient 86 86
Test Result 70 70
Foreign Body Reaction 69 69
No Patient Involvement 68 68
Unspecified Infection 42 42
Joint Dislocation 36 36
Osteolysis 26 26
Metal Related Pathology 26 26
Edema 23 23
Bone Fracture(s) 20 20
Hypersensitivity/Allergic reaction 15 15
Limited Mobility Of The Implanted Joint 15 15
Inadequate Osseointegration 14 14
Tissue Damage 13 13
Thrombosis 11 11
Discomfort 10 10
Injury 10 10
Reaction 10 10
Adhesion(s) 10 10
Not Applicable 8 8
Fatigue 8 8
Insufficient Information 7 7
Pulmonary Embolism 6 6
Weakness 6 6
Necrosis 6 6
No Information 6 6
Failure of Implant 6 6
Memory Loss/Impairment 5 5
Inflammation 5 5
Toxicity 5 5
Hematoma 4 4
Cyst(s) 4 4
Neuropathy 4 4
No Known Impact Or Consequence To Patient 4 4
Hearing Impairment 4 4
Nerve Damage 4 4
Tinnitus 4 4
Anxiety 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Swelling/ Edema 3 3
Fall 3 3
Ossification 3 3
Loss of Range of Motion 3 3
Joint Disorder 3 3
Pneumonia 2 2
Hair Loss 2 2
Pocket Erosion 2 2
Myocardial Infarction 2 2

-
-