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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, hemi-, femoral, metal
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeKWL
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 210 210
2017 347 347
2018 296 296
2019 415 415
2020 268 268
2021 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 354 354
Adverse Event Without Identified Device or Use Problem 247 247
Device-Device Incompatibility 203 203
Appropriate Term/Code Not Available 149 149
Loss of Osseointegration 145 145
Material Twisted/Bent 113 113
Break 109 109
Device Dislodged or Dislocated 76 76
Scratched Material 76 76
Corroded 55 55
Fitting Problem 48 48
Loose or Intermittent Connection 43 43
Fracture 38 38
Migration or Expulsion of Device 38 38
Naturally Worn 32 32
Material Deformation 27 27
Osseointegration Problem 27 27
Nonstandard Device 26 26
Degraded 26 26
Physical Resistance/Sticking 25 25
Migration 22 22
Inadequacy of Device Shape and/or Size 20 20
Detachment Of Device Component 16 16
Biocompatibility 11 11
Malposition of Device 10 10
Loss of or Failure to Bond 10 10
Difficult to Remove 10 10
Mechanical Jam 9 9
Material Integrity Problem 9 9
Device Contaminated During Manufacture or Shipping 9 9
Entrapment of Device 8 8
Difficult to Insert 7 7
Connection Problem 7 7
Defective Device 7 7
Noise, Audible 7 7
Patient Device Interaction Problem 6 6
Packaging Problem 6 6
Patient-Device Incompatibility 6 6
Device Operates Differently Than Expected 6 6
Mechanical Problem 6 6
Metal Shedding Debris 5 5
Compatibility Problem 5 5
Material Erosion 4 4
Material Discolored 4 4
Failure to Osseointegrate 4 4
Crack 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Device Slipped 3 3
Failure To Adhere Or Bond 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Damaged Prior to Use 2 2
Defective Component 2 2
Unstable 2 2
Delivered as Unsterile Product 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Advance 2 2
Device Contamination with Chemical or Other Material 2 2
Positioning Problem 2 2
Unintended Movement 2 2
Detachment of Device or Device Component 2 2
Use of Device Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Stretched 1 1
Material Disintegration 1 1
Device Expiration Issue 1 1
Material Fragmentation 1 1
Incorrect Measurement 1 1
Microbial Contamination of Device 1 1
Device Issue 1 1
No Device Output 1 1
Overheating of Device 1 1
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Improper Chemical Reaction 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Markings/Labelling Problem 1 1
Mechanics Altered 1 1
Vibration 1 1
Device Inoperable 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 392 392
Pain 364 364
No Code Available 334 334
Injury 213 213
Unspecified Infection 166 166
Bone Fracture(s) 137 137
No Information 126 126
Not Applicable 116 116
Inadequate Osseointegration 96 96
Test Result 77 77
Discomfort 72 72
Joint Dislocation 63 63
Foreign Body Reaction 61 61
Inflammation 58 58
Tissue Damage 56 56
Osteolysis 44 44
Reaction 40 40
Failure of Implant 39 39
Fall 37 37
Limited Mobility Of The Implanted Joint 37 37
No Known Impact Or Consequence To Patient 33 33
Host-Tissue Reaction 31 31
Loss of Range of Motion 27 27
Ambulation Difficulties 27 27
Distress 16 16
Weakness 15 15
Necrosis 15 15
Edema 15 15
Blood Loss 14 14
Swelling 14 14
Metal Related Pathology 13 13
Hypersensitivity/Allergic reaction 12 12
Thrombosis 8 8
Toxicity 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Synovitis 7 7
Anxiety 7 7
Hip Fracture 6 6
Cyst(s) 5 5
Fatigue 5 5
Hematoma 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Muscular Rigidity 5 5
Myocardial Infarction 4 4
Adhesion(s) 4 4
Depression 4 4
No Patient Involvement 4 4
Insufficient Information 4 4
Malaise 3 3
Death 3 3
Infarction, Cerebral 2 2
Bacterial Infection 2 2
Non-union Bone Fracture 2 2
Joint Disorder 2 2
Complaint, Ill-Defined 2 2
Joint Swelling 2 2
Pocket Erosion 2 2
Scar Tissue 2 2
Scarring 2 2
Confusion/ Disorientation 2 2
Deformity/ Disfigurement 2 2
Thrombus 2 2
Renal Failure 2 2
Arthritis 2 2
Erosion 2 2
Calcium Deposits/Calcification 2 2
Cardiomyopathy 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Anemia 1 1
Rash 1 1
Muscle Weakness 1 1
Sepsis 1 1
Hypoesthesia 1 1
Cancer 1 1
Renal Impairment 1 1
Osteopenia/ Osteoporosis 1 1
Fluid Discharge 1 1
Muscle/Tendon Damage 1 1
Physical Asymmetry 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Joint Laxity 1 1
Unspecified Tissue Injury 1 1
Seroma 1 1
Local Reaction 1 1
Heart Failure 1 1
Respiratory Tract Infection 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Ossification 1 1
Nerve Damage 1 1
Itching Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Oct-11-2018
2 DePuy Orthopaedics, Inc. II Feb-12-2018
3 Smith & Nephew, Inc. II Jan-05-2016
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