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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
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 294 294
2019 415 415
2020 269 269
2021 107 107
2022 98 98
2023 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 259 259
Device-Device Incompatibility 204 204
Insufficient Information 118 118
Material Twisted/Bent 113 113
Break 105 105
Biocompatibility 95 95
Appropriate Term/Code Not Available 84 84
Scratched Material 76 76
Loss of Osseointegration 50 50
Device Dislodged or Dislocated 47 47
Fitting Problem 44 44
Loose or Intermittent Connection 39 39
Corroded 30 30
Naturally Worn 30 30
Physical Resistance/Sticking 25 25
Osseointegration Problem 25 25
Fracture 24 24
Material Deformation 22 22
Migration 21 21
Degraded 19 19
Nonstandard Device 18 18
Device Contaminated During Manufacture or Shipping 16 16
Tear, Rip or Hole in Device Packaging 13 13
Inadequacy of Device Shape and/or Size 13 13
Migration or Expulsion of Device 13 13
Packaging Problem 12 12
Mechanical Jam 9 9
Material Integrity Problem 8 8
Difficult to Remove 8 8
Entrapment of Device 8 8
Patient Device Interaction Problem 8 8
Connection Problem 7 7
Defective Device 7 7
Patient-Device Incompatibility 6 6
Detachment of Device or Device Component 6 6
Failure to Osseointegrate 6 6
Difficult to Insert 6 6
Loss of or Failure to Bond 5 5
Malposition of Device 5 5
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Compatibility Problem 4 4
Material Discolored 4 4
Crack 4 4
Material Fragmentation 3 3
Mechanical Problem 3 3
Unstable 3 3
Use of Device Problem 3 3
Unintended Movement 3 3
Difficult to Advance 2 2
Device Markings/Labelling Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Unsealed Device Packaging 2 2
Failure To Adhere Or Bond 2 2
Detachment Of Device Component 2 2
Material Disintegration 1 1
Incorrect Measurement 1 1
Difficult To Position 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Stretched 1 1
No Device Output 1 1
Overheating of Device 1 1
Device Issue 1 1
Vibration 1 1
Metal Shedding Debris 1 1
Dull, Blunt 1 1
Device Disinfection Or Sterilization Issue 1 1
No Apparent Adverse Event 1 1
Noise, Audible 1 1
Mechanics Altered 1 1
Therapeutic or Diagnostic Output Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 382 382
No Code Available 272 272
Pain 237 237
Not Applicable 111 111
Unspecified Infection 110 110
Injury 103 103
Metal Related Pathology 103 103
Inadequate Osseointegration 87 87
Test Result 74 74
Bone Fracture(s) 65 65
Tissue Damage 46 46
Inflammation 45 45
Discomfort 44 44
Osteolysis 40 40
Joint Dislocation 36 36
No Clinical Signs, Symptoms or Conditions 35 35
Failure of Implant 32 32
Foreign Body Reaction 30 30
Loss of Range of Motion 29 29
Insufficient Information 28 28
Limited Mobility Of The Implanted Joint 28 28
Reaction 23 23
Fall 20 20
Ambulation Difficulties 18 18
No Known Impact Or Consequence To Patient 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Infiltration into Tissue 15 15
Blood Loss 14 14
No Information 13 13
Host-Tissue Reaction 11 11
Distress 11 11
Swelling 11 11
Hypersensitivity/Allergic reaction 10 10
Necrosis 10 10
Edema 9 9
Hematoma 7 7
Thrombosis 7 7
Hip Fracture 7 7
Arthralgia 7 7
Anxiety 6 6
Weakness 6 6
Swelling/ Edema 6 6
Synovitis 5 5
Toxicity 5 5
Cyst(s) 5 5
Fatigue 4 4
Myocardial Infarction 4 4
Depression 4 4
Implant Pain 4 4
No Patient Involvement 4 4
Joint Laxity 3 3
Solid Tumour 3 3
Unspecified Tissue Injury 3 3
Deformity/ Disfigurement 3 3
Scar Tissue 3 3
Ossification 3 3
Bacterial Infection 3 3
Infarction, Cerebral 2 2
Adhesion(s) 2 2
Nerve Damage 2 2
Muscle Weakness 2 2
Muscular Rigidity 2 2
Scarring 2 2
Pocket Erosion 2 2
Renal Failure 2 2
Thrombus 2 2
Non-union Bone Fracture 2 2
Joint Disorder 2 2
Confusion/ Disorientation 2 2
Muscle/Tendon Damage 2 2
Unequal Limb Length 1 1
Skin Infection 1 1
Physical Asymmetry 1 1
Thrombosis/Thrombus 1 1
Renal Impairment 1 1
Limb Fracture 1 1
Osteopenia/ Osteoporosis 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Numbness 1 1
Respiratory Tract Infection 1 1
Hypoesthesia 1 1
Tinnitus 1 1
Heart Failure 1 1
Sepsis 1 1
Rash 1 1
Local Reaction 1 1
Pneumonia 1 1
Itching Sensation 1 1
Hemorrhage/Bleeding 1 1
Hyperplasia 1 1
Headache 1 1
Wound Dehiscence 1 1
Death 1 1
Calcium Deposits/Calcification 1 1
Cardiomyopathy 1 1
Stroke/CVA 1 1
Pulmonary Embolism 1 1
Abrasion 1 1
Abscess 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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