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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 295 295
2019 415 415
2020 269 269
2021 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 357 357
Adverse Event Without Identified Device or Use Problem 259 259
Device-Device Incompatibility 203 203
Appropriate Term/Code Not Available 157 157
Loss of Osseointegration 145 145
Material Twisted/Bent 113 113
Break 112 112
Device Dislodged or Dislocated 80 80
Scratched Material 76 76
Corroded 55 55
Fitting Problem 48 48
Loose or Intermittent Connection 43 43
Fracture 39 39
Migration or Expulsion of Device 38 38
Naturally Worn 32 32
Biocompatibility 28 28
Material Deformation 27 27
Osseointegration Problem 27 27
Degraded 27 27
Nonstandard Device 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
Packaging Problem 11 11
Malposition of Device 10 10
Difficult to Remove 10 10
Loss of or Failure to Bond 10 10
Material Integrity Problem 9 9
Mechanical Jam 9 9
Device Contaminated During Manufacture or Shipping 9 9
Entrapment of Device 8 8
Patient Device Interaction Problem 8 8
Noise, Audible 7 7
Difficult to Insert 7 7
Connection Problem 7 7
Defective Device 7 7
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
Tear, Rip or Hole in Device Packaging 4 4
Failure to Osseointegrate 4 4
Material Erosion 4 4
Material Discolored 4 4
Crack 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Failure To Adhere Or Bond 3 3
Material Fragmentation 3 3
Unstable 3 3
Device Slipped 3 3
Detachment of Device or Device Component 3 3
Device Markings/Labelling Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Difficult to Advance 2 2
Positioning Problem 2 2
Use of Device Problem 2 2
Delivered as Unsterile Product 2 2
Unsealed Device Packaging 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
No Device Output 1 1
Overheating of Device 1 1
Vibration 1 1
Stretched 1 1
Device Inoperable 1 1
Device Expiration Issue 1 1
Incorrect Measurement 1 1
Material Disintegration 1 1
Mechanics Altered 1 1
Improper Chemical Reaction 1 1
Microbial Contamination of Device 1 1
Device Issue 1 1
Dull, Blunt 1 1
Device Disinfection Or Sterilization Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 392 392
Pain 381 381
No Code Available 334 334
Injury 213 213
Unspecified Infection 171 171
Bone Fracture(s) 139 139
No Information 126 126
Not Applicable 116 116
Inadequate Osseointegration 96 96
Test Result 77 77
Discomfort 73 73
Joint Dislocation 66 66
Foreign Body Reaction 61 61
Inflammation 57 57
Tissue Damage 56 56
Osteolysis 48 48
Failure of Implant 48 48
Metal Related Pathology 40 40
Reaction 39 39
Fall 37 37
Limited Mobility Of The Implanted Joint 37 37
No Known Impact Or Consequence To Patient 33 33
Loss of Range of Motion 32 32
Host-Tissue Reaction 31 31
Ambulation Difficulties 27 27
Distress 17 17
Weakness 15 15
Edema 15 15
Necrosis 15 15
Hypersensitivity/Allergic reaction 14 14
Swelling 14 14
Blood Loss 14 14
No Clinical Signs, Symptoms or Conditions 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Insufficient Information 10 10
Synovitis 8 8
Thrombosis 8 8
Toxicity 8 8
Hip Fracture 7 7
Anxiety 7 7
Hematoma 5 5
Muscular Rigidity 5 5
Fatigue 5 5
Adhesion(s) 5 5
Cyst(s) 5 5
Myocardial Infarction 4 4
Depression 4 4
No Patient Involvement 4 4
Swelling/ Edema 3 3
Unspecified Tissue Injury 3 3
Malaise 3 3
Scar Tissue 3 3
Death 3 3
Infarction, Cerebral 2 2
Arthritis 2 2
Bacterial Infection 2 2
Erosion 2 2
Calcium Deposits/Calcification 2 2
Pocket Erosion 2 2
Infiltration into Tissue 2 2
Scarring 2 2
Thrombus 2 2
Renal Failure 2 2
Deformity/ Disfigurement 2 2
Complaint, Ill-Defined 2 2
Non-union Bone Fracture 2 2
Joint Disorder 2 2
Confusion/ Disorientation 2 2
Joint Swelling 2 2
Cancer 1 1
Thrombosis/Thrombus 1 1
Renal Impairment 1 1
Joint Laxity 1 1
Osteopenia/ Osteoporosis 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Physical Asymmetry 1 1
Muscle/Tendon Damage 1 1
Respiratory Tract Infection 1 1
Hypoesthesia 1 1
Heart Failure 1 1
Rash 1 1
Local Reaction 1 1
Sepsis 1 1
Seroma 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Pneumonia 1 1
Nerve Damage 1 1
Cardiac Arrest 1 1
Cardiomyopathy 1 1
Stroke/CVA 1 1
Ossification 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Anemia 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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