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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
2015 222 222
2016 210 210
2017 347 347
2018 296 296
2019 414 414
2020 231 231

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 451 451
Adverse Event Without Identified Device or Use Problem 241 241
Device-Device Incompatibility 202 202
Loss of Osseointegration 177 177
Appropriate Term/Code Not Available 168 168
Break 113 113
Material Twisted/Bent 112 112
Device Dislodged or Dislocated 89 89
Scratched Material 76 76
Corroded 60 60
Fitting Problem 57 57
Migration or Expulsion of Device 56 56
Fracture 47 47
Loose or Intermittent Connection 46 46
Naturally Worn 36 36
Degraded 30 30
Nonstandard Device 26 26
Material Deformation 25 25
Physical Resistance/Sticking 25 25
Osseointegration Problem 24 24
Inadequacy of Device Shape and/or Size 22 22
Migration 20 20
Detachment Of Device Component 17 17
Loss of or Failure to Bond 13 13
Device Operates Differently Than Expected 12 12
Malposition of Device 12 12
Biocompatibility 11 11
Difficult to Remove 11 11
Material Integrity Problem 10 10
Mechanical Jam 9 9
Noise, Audible 9 9
Metal Shedding Debris 8 8
Device Slipped 8 8
Mechanical Problem 8 8
Connection Problem 8 8
Entrapment of Device 8 8
Positioning Problem 7 7
Defective Device 7 7
Patient-Device Incompatibility 6 6
Device Contaminated During Manufacture or Shipping 6 6
Difficult to Insert 6 6
Material Erosion 4 4
Material Discolored 4 4
Unstable 4 4
Failure to Osseointegrate 4 4
Packaging Problem 4 4
Crack 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Patient Device Interaction Problem 3 3
Material Disintegration 3 3
Failure To Adhere Or Bond 3 3
Device Contamination with Chemical or Other Material 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Difficult to Advance 2 2
Tear, Rip or Hole in Device Packaging 2 2
Delivered as Unsterile Product 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Unintended Movement 2 2
Use of Device Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Tip 1 1
Misassembly by Users 1 1
No Apparent Adverse Event 1 1
Microbial Contamination of Device 1 1
Device Issue 1 1
Detachment of Device or Device Component 1 1
Device Packaging Compromised 1 1
Device Expiration Issue 1 1
Incorrect Measurement 1 1
Cap 1 1
Cup 1 1
Ring 1 1
Stretched 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
Device Subassembly 1 1
Handpiece 1 1
Residue After Decontamination 1 1
Vibration 1 1
Device Inoperable 1 1
Dull, Blunt 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Markings/Labelling Problem 1 1
Improper Chemical Reaction 1 1
Compatibility Problem 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 418 418
No Consequences Or Impact To Patient 398 398
No Code Available 377 377
Injury 237 237
Unspecified Infection 184 184
No Information 166 166
Bone Fracture(s) 162 162
Not Applicable 116 116
Inadequate Osseointegration 93 93
Discomfort 82 82
Test Result 76 76
Joint Dislocation 70 70
Inflammation 66 66
Foreign Body Reaction 63 63
Tissue Damage 58 58
No Known Impact Or Consequence To Patient 48 48
Osteolysis 46 46
Fall 45 45
Host-Tissue Reaction 44 44
Reaction 39 39
Limited Mobility Of The Implanted Joint 39 39
Failure of Implant 34 34
Ambulation Difficulties 29 29
Loss of Range of Motion 24 24
Distress 17 17
Weakness 16 16
Necrosis 16 16
Edema 15 15
Swelling 15 15
Blood Loss 14 14
Hypersensitivity/Allergic reaction 13 13
Synovitis 9 9
Thrombosis 8 8
Toxicity 7 7
Anxiety 7 7
Muscular Rigidity 5 5
Hip Fracture 5 5
Fatigue 5 5
Hematoma 5 5
Cyst(s) 4 4
Myocardial Infarction 4 4
Adhesion(s) 4 4
Depression 4 4
Complaint, Ill-Defined 4 4
Ossification 3 3
Death 3 3
No Patient Involvement 3 3
Malaise 3 3
Deformity/ Disfigurement 2 2
Thrombus 2 2
Fluid Discharge 2 2
Renal Failure 2 2
Arthritis 2 2
Erosion 2 2
Calcium Deposits/Calcification 2 2
Confusion/ Disorientation 2 2
Infarction, Cerebral 2 2
Pocket Erosion 2 2
Joint Swelling 2 2
Non-union Bone Fracture 2 2
Joint Disorder 2 2
Scar Tissue 2 2
Scarring 2 2
Seroma 1 1
Heart Failure 1 1
Respiratory Tract Infection 1 1
Local Reaction 1 1
Nerve Damage 1 1
Itching Sensation 1 1
Cardiac Arrest 1 1
Stroke/CVA 1 1
Hemorrhage/Bleeding 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Anemia 1 1
Rash 1 1
Muscle Weakness 1 1
Cancer 1 1
Osteopenia/ Osteoporosis 1 1
Hypoesthesia 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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