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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 295 295
2019 415 415
2020 269 269
2021 108 108
2022 99 99
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 250 250
Device-Device Incompatibility 204 204
Material Twisted/Bent 113 113
Insufficient Information 112 112
Break 105 105
Appropriate Term/Code Not Available 86 86
Biocompatibility 81 81
Scratched Material 76 76
Loss of Osseointegration 50 50
Device Dislodged or Dislocated 44 44
Fitting Problem 44 44
Loose or Intermittent Connection 39 39
Corroded 31 31
Naturally Worn 29 29
Physical Resistance/Sticking 25 25
Osseointegration Problem 25 25
Fracture 24 24
Material Deformation 22 22
Migration 21 21
Degraded 18 18
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 273 273
Pain 236 236
Not Applicable 111 111
Unspecified Infection 105 105
Injury 104 104
Metal Related Pathology 93 93
Inadequate Osseointegration 87 87
Test Result 75 75
Bone Fracture(s) 65 65
Tissue Damage 46 46
Inflammation 45 45
Discomfort 45 45
Osteolysis 37 37
No Clinical Signs, Symptoms or Conditions 35 35
Joint Dislocation 33 33
Failure of Implant 32 32
Loss of Range of Motion 31 31
Foreign Body Reaction 31 31
Limited Mobility Of The Implanted Joint 28 28
Reaction 23 23
Insufficient Information 22 22
Fall 20 20
No Known Impact Or Consequence To Patient 17 17
Ambulation Difficulties 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Blood Loss 14 14
No Information 13 13
Distress 12 12
Host-Tissue Reaction 11 11
Hypersensitivity/Allergic reaction 11 11
Swelling 11 11
Infiltration into Tissue 10 10
Edema 9 9
Necrosis 9 9
Hip Fracture 7 7
Weakness 7 7
Thrombosis 7 7
Anxiety 6 6
Swelling/ Edema 6 6
Hematoma 6 6
Toxicity 5 5
Synovitis 5 5
Fatigue 5 5
No Patient Involvement 4 4
Cyst(s) 4 4
Arthralgia 4 4
Depression 4 4
Myocardial Infarction 4 4
Joint Laxity 3 3
Bacterial Infection 3 3
Unspecified Tissue Injury 3 3
Ossification 3 3
Scar Tissue 3 3
Deformity/ Disfigurement 3 3
Muscle/Tendon Damage 2 2
Adhesion(s) 2 2
Pocket Erosion 2 2
Confusion/ Disorientation 2 2
Muscular Rigidity 2 2
Infarction, Cerebral 2 2
Non-union Bone Fracture 2 2
Joint Disorder 2 2
Renal Failure 2 2
Scarring 2 2
Solid Tumour 2 2
Nerve Damage 2 2
Thrombus 2 2
Calcium Deposits/Calcification 2 2
Rash 1 1
Abscess 1 1
Osteopenia/ Osteoporosis 1 1
Physical Asymmetry 1 1
Headache 1 1
Itching Sensation 1 1
Dizziness 1 1
Pneumonia 1 1
Unequal Limb Length 1 1
Hypoesthesia 1 1
Erosion 1 1
Diaphoresis 1 1
Respiratory Tract Infection 1 1
Local Reaction 1 1
Tinnitus 1 1
Hemorrhage/Bleeding 1 1
Patient Problem/Medical Problem 1 1
Arrhythmia 1 1
Stroke/CVA 1 1
Death 1 1
Foreign Body In Patient 1 1
Heart Failure 1 1
Implant Pain 1 1
Skin Infection 1 1
Pulmonary Embolism 1 1
Abrasion 1 1
Cardiomyopathy 1 1
Thrombosis/Thrombus 1 1
Renal Impairment 1 1
Limb Fracture 1 1
Hyperplasia 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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