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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)
2020 2021 2022 2023 2024 2025
22 20 20 13 11 2

MDR Year MDR Reports MDR Events
2020 441 441
2021 375 375
2022 305 305
2023 471 471
2024 292 292
2025 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1254 1254
Patient-Device Incompatibility 108 108
Insufficient Information 102 102
Off-Label Use 53 53
Break 36 36
Use of Device Problem 29 29
Therapeutic or Diagnostic Output Failure 28 28
Patient Device Interaction Problem 24 24
Improper or Incorrect Procedure or Method 21 21
Appropriate Term/Code Not Available 16 16
Microbial Contamination of Device 14 14
Lack of Effect 9 9
No Apparent Adverse Event 8 8
Leak/Splash 8 8
Unexpected Therapeutic Results 6 6
Detachment of Device or Device Component 5 5
Fluid/Blood Leak 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Failure to Deliver 3 3
Output Problem 3 3
Device Fell 2 2
Defective Device 2 2
Contamination /Decontamination Problem 2 2
Device Markings/Labelling Problem 2 2
Device Handling Problem 2 2
Product Quality Problem 2 2
Material Separation 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Contamination with Chemical or Other Material 2 2
Fracture 2 2
Device Appears to Trigger Rejection 2 2
Material Integrity Problem 1 1
Device Damaged Prior to Use 1 1
Crack 1 1
Shipping Damage or Problem 1 1
Misfire 1 1
Unintended Ejection 1 1
Component Missing 1 1
Application Program Problem: Medication Error 1 1
Burst Container or Vessel 1 1
Activation, Positioning or Separation Problem 1 1
Unstable 1 1
Explosion 1 1
Inaccurate Delivery 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Device Slipped 1 1
Nonstandard Device 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 386 386
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 322 322
Arthralgia 271 271
Ambulation Difficulties 247 247
Swelling/ Edema 231 231
Insufficient Information 223 223
No Code Available 156 156
No Clinical Signs, Symptoms or Conditions 109 109
Hypersensitivity/Allergic reaction 100 100
Joint Swelling 88 88
Arthritis 80 80
Inflammation 68 68
Rash 68 68
Unspecified Infection 63 63
Loss of Range of Motion 60 60
Bacterial Infection 57 57
Swelling 53 53
Synovitis 45 45
Headache 43 43
Erythema 41 41
Peripheral Edema 39 39
Nausea 38 39
No Known Impact Or Consequence To Patient 35 35
Cancer 35 35
Dyspnea 35 35
Itching Sensation 34 34
Fatigue 31 31
Fever 30 30
Therapeutic Response, Decreased 30 30
Injection Site Reaction 27 27
Death 25 25
Muscle Weakness 25 25
Discomfort 24 24
Dizziness 23 23
Sleep Dysfunction 23 23
Myalgia 22 22
Burning Sensation 20 20
Thrombosis/Thrombus 19 19
Inadequate Pain Relief 19 19
Fall 18 18
Numbness 18 18
High Blood Pressure/ Hypertension 17 17
Chills 16 16
Myocardial Infarction 16 16
Malaise 15 15
Necrosis 15 15
Bone Fracture(s) 15 15
Joint Disorder 15 15
Reaction 15 15
Shaking/Tremors 14 14

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