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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device acid, hyaluronic, intraarticular
Product CodeMOZ
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
21 12 22 20 20 4

MDR Year MDR Reports MDR Events
2018 1096 1096
2019 567 567
2020 441 441
2021 376 376
2022 305 305

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1615 1615
Device Contamination With Biological Material 441 441
Patient-Device Incompatibility 220 220
Microbial Contamination of Device 163 163
Insufficient Information 152 152
Off-Label Use 99 99
Nonstandard Device 71 71
Appropriate Term/Code Not Available 36 36
Therapeutic or Diagnostic Output Failure 34 34
Improper or Incorrect Procedure or Method 28 28
Patient Device Interaction Problem 12 12
Break 11 11
Unexpected Therapeutic Results 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Device Operates Differently Than Expected 9 9
Use of Device Problem 8 8
Leak/Splash 7 7
Detachment of Device or Device Component 7 7
No Apparent Adverse Event 6 6
Device Markings/Labelling Problem 5 5
Defective Device 5 5
Loss of Data 4 4
Contamination 4 4
Product Quality Problem 4 4
Failure to Deliver 3 3
Device Fell 3 3
Device Dislodged or Dislocated 2 2
Device Contamination with Chemical or Other Material 2 2
Output Problem 2 2
Missing Value Reason 2 2
Inaccurate Delivery 2 2
Defective Component 2 2
Contamination of Device Ingredient or Reagent 2 2
Expiration Date Error 2 2
Device Appears to Trigger Rejection 2 2
Material Separation 2 2
Fluid/Blood Leak 2 2
Fracture 1 1
No Display/Image 1 1
Unintended Ejection 1 1
Burst Container or Vessel 1 1
Shipping Damage or Problem 1 1
Device Inoperable 1 1
Unstable 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Therapy Delivered to Incorrect Body Area 1 1
Misfire 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Damaged Prior to Use 1 1
Tear, Rip or Hole in Device Packaging 1 1
Component Missing 1 1
Patient Data Problem 1 1
Protective Measures Problem 1 1
Human-Device Interface Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 812 812
Pain 744 744
Arthralgia 660 660
Joint Swelling 482 482
Swelling 373 373
Ambulation Difficulties 261 261
Joint Disorder 188 188
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 187 187
Arthritis 152 152
Swelling/ Edema 126 126
Reaction, Injection Site 122 122
Hypersensitivity/Allergic reaction 115 115
Inflammation 109 109
No Known Impact Or Consequence To Patient 107 107
Unspecified Infection 105 105
Insufficient Information 104 104
Erythema 95 95
Bacterial Infection 86 86
Loss of Range of Motion 85 85
Synovitis 76 76
Death 75 75
Fever 75 75
Rash 73 73
Nausea 62 63
Therapeutic Response, Decreased 59 59
Reaction 57 57
Fatigue 53 53
Headache 47 47
Discomfort 47 47
Chills 46 46
Itching Sensation 43 43
Sleep Dysfunction 42 42
Fall 40 40
Edema 38 38
Dizziness 38 38
Toxicity 36 36
Dyspnea 35 35
Burning Sensation 33 33
Muscle Weakness 32 32
Weakness 30 30
Muscle Spasm(s) 29 29
Inadequate Pain Relief 28 28
Myalgia 26 26
Urticaria 24 24
Numbness 24 24
No Information 21 21
No Clinical Signs, Symptoms or Conditions 21 21
Injury 20 20
Vomiting 20 20
Malaise 19 19
Cyst(s) 19 19
Shaking/Tremors 18 18
Disability 17 17
Skin Inflammation 16 16
Sweating 15 15
Sepsis 15 15
High Blood Pressure/ Hypertension 15 15
Aspiration/Inhalation 14 14
Loss of consciousness 14 14
Hypoesthesia 13 13
Alteration In Body Temperature 13 13
Muscular Rigidity 13 13
Diarrhea 12 12
Bone Fracture(s) 12 12
Complaint, Ill-Defined 12 12
Neck Stiffness 11 11
Missed Dose 11 11
Cancer 11 11
Abdominal Pain 11 11
Necrosis 11 11
Paralysis 11 11
Skin Discoloration 11 11
Local Reaction 10 10
Anaphylactic Shock 10 10
Injection Site Reaction 10 10
Neck Pain 9 9
Anxiety 9 9
Cramp(s) 9 9
Myocardial Infarction 9 9
Hyperglycemia 8 8
Neuropathy 8 8
Therapeutic Effects, Unexpected 8 8
Thrombosis 8 8
Hot Flashes/Flushes 8 8
Syncope 8 8
Arrhythmia 8 8
Chest Pain 8 8
Tingling 8 8
Thrombosis/Thrombus 8 8
Cramp(s) /Muscle Spasm(s) 8 8
Fluid Discharge 8 8
Patient Problem/Medical Problem 7 7
Bruise/Contusion 7 7
Atrial Fibrillation 7 7
Stroke/CVA 7 7
Blurred Vision 7 7
Urinary Tract Infection 6 6
Pneumonia 6 6
Low Blood Pressure/ Hypotension 6 6
Memory Loss/Impairment 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Sanofi Genzyme II Feb-14-2018
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