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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
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 415 415
2020 269 269
2021 107 107
2022 99 99
2023 49 49
2024 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 232 232
Device-Device Incompatibility 193 193
Material Twisted/Bent 110 110
Break 104 104
Biocompatibility 98 98
Loss of Osseointegration 93 93
Scratched Material 75 75
Device Dislodged or Dislocated 47 47
Insufficient Information 44 44
Naturally Worn 35 35
Fitting Problem 30 30
Loose or Intermittent Connection 30 30
Appropriate Term/Code Not Available 26 26
Physical Resistance/Sticking 24 24
Material Deformation 21 21
Migration 18 18
Device Contaminated During Manufacture or Shipping 16 16
Fracture 16 16
Nonstandard Device 14 14
Tear, Rip or Hole in Device Packaging 13 13
Degraded 12 12
Osseointegration Problem 12 12
Corroded 11 11
Packaging Problem 10 10
Mechanical Jam 9 9
Inadequacy of Device Shape and/or Size 9 9
Difficult to Remove 7 7
Computer System Security Problem 7 7
Entrapment of Device 7 7
Material Integrity Problem 7 7
Detachment of Device or Device Component 7 7
Patient Device Interaction Problem 7 7
Connection Problem 6 6
Malposition of Device 6 6
Patient-Device Incompatibility 5 5
Defective Device 4 4
Difficult to Insert 4 4
Compatibility Problem 4 4
Unintended Movement 3 3
Unstable 3 3
Use of Device Problem 3 3
Failure to Osseointegrate 3 3
Material Fragmentation 3 3
Crack 3 3
Mechanical Problem 3 3
Migration or Expulsion of Device 3 3
Unsealed Device Packaging 2 2
Material Discolored 2 2
Loss of or Failure to Bond 2 2
Device Damaged Prior to Use 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Difficult to Advance 2 2
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Defective Component 1 1
Dull, Blunt 1 1
Material Disintegration 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
No Device Output 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 320 320
No Code Available 226 226
Pain 154 154
Insufficient Information 111 111
Metal Related Pathology 105 105
Unspecified Infection 85 85
Not Applicable 60 60
Injury 49 49
Test Result 47 47
Bone Fracture(s) 44 44
Inadequate Osseointegration 41 41
Joint Dislocation 36 36
No Clinical Signs, Symptoms or Conditions 35 35
Osteolysis 31 31
Failure of Implant 29 29
Tissue Damage 21 21
Discomfort 20 20
Foreign Body Reaction 20 20
Loss of Range of Motion 17 17
Infiltration into Tissue 15 15
Limited Mobility Of The Implanted Joint 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Inflammation 13 13
Fall 12 12
No Known Impact Or Consequence To Patient 11 11
Ambulation Difficulties 11 11
Leiomyosarcoma 11 11
Arthralgia 9 9
Edema 8 8
No Information 8 8
Hematoma 6 6
Necrosis 6 6
Hypersensitivity/Allergic reaction 5 5
Hip Fracture 5 5
Swelling/ Edema 5 5
Implant Pain 4 4
Joint Laxity 4 4
Toxicity 4 4
Swelling 4 4
Synovitis 4 4
Thrombosis 4 4
Blood Loss 4 4
No Patient Involvement 4 4
Cyst(s) 4 4
Ossification 3 3
Bacterial Infection 3 3
Distress 3 3
Solid Tumour 3 3
Muscle/Tendon Damage 2 2
Limb Fracture 2 2
Foreign Body In Patient 2 2
Reaction 2 2
Thrombus 2 2
Myocardial Infarction 2 2
Anxiety 2 2
Host-Tissue Reaction 2 2
Muscle Weakness 2 2
Muscular Rigidity 1 1
Hemorrhage/Bleeding 1 1
Hyperplasia 1 1
Headache 1 1
Nerve Damage 1 1
Local Reaction 1 1
Renal Failure 1 1
Scar Tissue 1 1
Sepsis 1 1
Wound Dehiscence 1 1
Death 1 1
Fatigue 1 1
Fistula 1 1
Calcium Deposits/Calcification 1 1
Cardiomyopathy 1 1
Stroke/CVA 1 1
Abrasion 1 1
Abscess 1 1
Adhesion(s) 1 1
Heart Failure 1 1
Hypoesthesia 1 1
Tinnitus 1 1
Weakness 1 1
Pneumonia 1 1
Pocket Erosion 1 1
Numbness 1 1
Respiratory Tract Infection 1 1
Depression 1 1
Joint Disorder 1 1
Fluid Discharge 1 1
Osteopenia/ Osteoporosis 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Thrombosis/Thrombus 1 1
Renal Impairment 1 1
Unequal Limb Length 1 1
Skin Infection 1 1
Unspecified Tissue Injury 1 1

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