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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
2017 347 347
2018 295 295
2019 415 415
2020 269 269
2021 107 107
2022 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 286 286
Adverse Event Without Identified Device or Use Problem 269 269
Device-Device Incompatibility 204 204
Appropriate Term/Code Not Available 116 116
Material Twisted/Bent 113 113
Break 106 106
Loss of Osseointegration 91 91
Scratched Material 76 76
Device Dislodged or Dislocated 75 75
Biocompatibility 70 70
Corroded 50 50
Fitting Problem 48 48
Loose or Intermittent Connection 42 42
Fracture 37 37
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
Device Contaminated During Manufacture or Shipping 16 16
Inadequacy of Device Shape and/or Size 15 15
Packaging Problem 13 13
Tear, Rip or Hole in Device Packaging 13 13
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
Defective Device 7 7
Connection Problem 7 7
Detachment of Device or Device Component 6 6
Failure to Osseointegrate 6 6
Patient-Device Incompatibility 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
Unstable 3 3
Use of Device Problem 3 3
Metal Shedding Debris 3 3
Unintended Movement 3 3
Device Markings/Labelling Problem 2 2
Difficult to Advance 2 2
Device Contamination with Chemical or Other Material 2 2
Positioning Problem 2 2
Device Damaged Prior to Use 2 2
Defective Component 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
Microbial Contamination of Device 1 1
Device Issue 1 1
Vibration 1 1
Stretched 1 1
Mechanics Altered 1 1
Therapeutic or Diagnostic Output Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Dull, Blunt 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 390 390
Pain 326 326
No Code Available 306 306
Injury 177 177
Unspecified Infection 156 156
Not Applicable 114 114
Bone Fracture(s) 97 97
Inadequate Osseointegration 95 95
No Information 90 90
Metal Related Pathology 84 84
Test Result 76 76
Joint Dislocation 60 60
Discomfort 59 59
Tissue Damage 55 55
Inflammation 52 52
Osteolysis 48 48
Failure of Implant 46 46
Foreign Body Reaction 44 44
Reaction 39 39
Loss of Range of Motion 34 34
No Clinical Signs, Symptoms or Conditions 34 34
Limited Mobility Of The Implanted Joint 33 33
Fall 31 31
Ambulation Difficulties 28 28
No Known Impact Or Consequence To Patient 24 24
Host-Tissue Reaction 22 22
Insufficient Information 20 20
Distress 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Blood Loss 14 14
Swelling 14 14
Edema 13 13
Hypersensitivity/Allergic reaction 12 12
Necrosis 12 12
Weakness 12 12
Thrombosis 8 8
Infiltration into Tissue 8 8
Hematoma 7 7
Hip Fracture 7 7
Anxiety 7 7
Toxicity 6 6
Synovitis 6 6
Swelling/ Edema 6 6
Adhesion(s) 5 5
Cyst(s) 4 4
Fatigue 4 4
Muscular Rigidity 4 4
Myocardial Infarction 4 4
Depression 4 4
No Patient Involvement 4 4
Deformity/ Disfigurement 3 3
Unspecified Tissue Injury 3 3
Arthralgia 3 3
Scar Tissue 3 3
Death 3 3
Ossification 3 3
Bacterial Infection 3 3
Erosion 2 2
Calcium Deposits/Calcification 2 2
Infarction, Cerebral 2 2
Scarring 2 2
Pocket Erosion 2 2
Thrombus 2 2
Non-union Bone Fracture 2 2
Joint Disorder 2 2
Renal Failure 2 2
Complaint, Ill-Defined 2 2
Joint Laxity 2 2
Muscle/Tendon Damage 2 2
Confusion/ Disorientation 2 2
Tissue Breakdown 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Osteopenia/ Osteoporosis 1 1
Cancer 1 1
Thrombosis/Thrombus 1 1
Renal Impairment 1 1
Limb Fracture 1 1
Unequal Limb Length 1 1
Skin Infection 1 1
Solid Tumour 1 1
Physical Asymmetry 1 1
Hypoesthesia 1 1
Joint Swelling 1 1
Malaise 1 1
Respiratory Tract Infection 1 1
Heart Failure 1 1
Rash 1 1
Local Reaction 1 1
Sepsis 1 1
Seroma 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

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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