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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
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
2017 347 347
2018 295 295
2019 415 415
2020 269 269
2021 107 107
2022 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 286 286
Adverse Event Without Identified Device or Use Problem 252 252
Device-Device Incompatibility 203 203
Appropriate Term/Code Not Available 114 114
Material Twisted/Bent 113 113
Break 104 104
Loss of Osseointegration 91 91
Scratched Material 76 76
Device Dislodged or Dislocated 72 72
Fitting Problem 48 48
Corroded 48 48
Biocompatibility 43 43
Loose or Intermittent Connection 42 42
Fracture 35 35
Naturally Worn 31 31
Material Deformation 27 27
Osseointegration Problem 26 26
Migration or Expulsion of Device 25 25
Physical Resistance/Sticking 25 25
Degraded 24 24
Nonstandard Device 22 22
Migration 21 21
Inadequacy of Device Shape and/or Size 15 15
Device Contaminated During Manufacture or Shipping 14 14
Packaging Problem 13 13
Tear, Rip or Hole in Device Packaging 12 12
Detachment Of Device Component 10 10
Difficult to Remove 9 9
Mechanical Jam 9 9
Material Integrity Problem 8 8
Malposition of Device 8 8
Entrapment of Device 8 8
Patient Device Interaction Problem 8 8
Difficult to Insert 7 7
Loss of or Failure to Bond 7 7
Connection Problem 7 7
Defective Device 7 7
Patient-Device Incompatibility 6 6
Failure to Osseointegrate 6 6
Noise, Audible 6 6
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Device Operates Differently Than Expected 5 5
Compatibility Problem 5 5
Material Discolored 4 4
Crack 4 4
Mechanical Problem 4 4
Material Fragmentation 3 3
Failure To Adhere Or Bond 3 3
Metal Shedding Debris 3 3
Use of Device Problem 3 3
Detachment of Device or Device Component 3 3
Unintended Movement 3 3
Device Markings/Labelling Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Positioning Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Difficult to Advance 2 2
Unstable 2 2
Unsealed Device Packaging 2 2
Material Erosion 2 2
Device Expiration Issue 1 1
Incorrect Measurement 1 1
Material Disintegration 1 1
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Delivered as Unsterile Product 1 1
No Device Output 1 1
Overheating of Device 1 1
Stretched 1 1
Vibration 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanics Altered 1 1
Microbial Contamination of Device 1 1
Device Issue 1 1
Dull, Blunt 1 1
Device Disinfection Or Sterilization Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 390 390
Pain 317 317
No Code Available 306 306
Injury 177 177
Unspecified Infection 151 151
Not Applicable 114 114
Inadequate Osseointegration 95 95
No Information 90 90
Bone Fracture(s) 90 90
Test Result 76 76
Metal Related Pathology 58 58
Discomfort 57 57
Joint Dislocation 57 57
Tissue Damage 55 55
Inflammation 51 51
Osteolysis 46 46
Foreign Body Reaction 43 43
Failure of Implant 43 43
Reaction 39 39
Limited Mobility Of The Implanted Joint 33 33
Loss of Range of Motion 32 32
Fall 29 29
Ambulation Difficulties 28 28
No Clinical Signs, Symptoms or Conditions 28 28
No Known Impact Or Consequence To Patient 24 24
Host-Tissue Reaction 22 22
Distress 16 16
Insufficient Information 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Blood Loss 14 14
Swelling 14 14
Edema 13 13
Hypersensitivity/Allergic reaction 12 12
Weakness 12 12
Necrosis 11 11
Thrombosis 8 8
Anxiety 7 7
Hip Fracture 7 7
Toxicity 6 6
Hematoma 5 5
Adhesion(s) 5 5
Swelling/ Edema 5 5
No Patient Involvement 4 4
Cyst(s) 4 4
Infiltration into Tissue 4 4
Muscular Rigidity 4 4
Myocardial Infarction 4 4
Depression 4 4
Synovitis 4 4
Scar Tissue 3 3
Death 3 3
Fatigue 3 3
Ossification 3 3
Unspecified Tissue Injury 3 3
Deformity/ Disfigurement 2 2
Bacterial Infection 2 2
Erosion 2 2
Calcium Deposits/Calcification 2 2
Infarction, Cerebral 2 2
Pocket Erosion 2 2
Scarring 2 2
Renal Failure 2 2
Thrombus 2 2
Non-union Bone Fracture 2 2
Joint Disorder 2 2
Confusion/ Disorientation 2 2
Complaint, Ill-Defined 2 2
Hypoesthesia 1 1
Joint Swelling 1 1
Malaise 1 1
Respiratory Tract Infection 1 1
Heart Failure 1 1
Sepsis 1 1
Seroma 1 1
Rash 1 1
Local Reaction 1 1
Pneumonia 1 1
Nerve Damage 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Hemorrhage/Bleeding 1 1
Anemia 1 1
Arthritis 1 1
Cardiac Arrest 1 1
Cardiomyopathy 1 1
Stroke/CVA 1 1
Pulmonary Embolism 1 1
Abrasion 1 1
Abscess 1 1
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
Patient Problem/Medical Problem 1 1
Physical Asymmetry 1 1
Muscle/Tendon Damage 1 1
Unequal Limb Length 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Oct-11-2018
2 DePuy Orthopaedics, Inc. II Feb-12-2018
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