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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)
2021 2022 2023 2024 2025 2026
20 20 13 11 13 1

MDR Year MDR Reports MDR Events
2021 375 399
2022 305 325
2023 470 470
2024 292 292
2025 186 186
2026 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1058 1076
Insufficient Information 104 104
Patient-Device Incompatibility 74 92
Patient Device Interaction Problem 43 44
Break 36 37
Use of Device Problem 36 36
Off-Label Use 30 30
Therapeutic or Diagnostic Output Failure 22 23
Improper or Incorrect Procedure or Method 19 19
No Apparent Adverse Event 17 17
Appropriate Term/Code Not Available 15 15
Lack of Effect 11 11
Contamination 9 9
Unexpected Therapeutic Results 5 6
Output Problem 5 5
Fluid/Blood Leak 4 4
Leak/Splash 4 4
Device Appears to Trigger Rejection 4 5
Component Missing 3 3
Detachment of Device or Device Component 3 7
Device Markings/Labelling Problem 3 3
Material Integrity Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Contamination of Device Ingredient or Reagent 2 2
Material Separation 2 2
Device Damaged Prior to Use 2 2
Fracture 2 2
Crack 2 2
Device Handling Problem 2 2
Device Fell 2 2
Migration 1 1
Explosion 1 1
Application Program Problem: Medication Error 1 1
Unintended Ejection 1 1
Burst Container or Vessel 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Microbial Contamination of Device 1 1
Device Slipped 1 1
Activation, Positioning or Separation Problem 1 1
Biocompatibility 1 1
Contamination /Decontamination Problem 1 1
Failure to Deliver 1 5
Inaccurate Delivery 1 1
Expiration Date Error 1 1
Misfire 1 1
Defective Device 1 1
Human-Device Interface Problem 1 1
Improper Chemical Reaction 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 330 333
Pain 305 326
Swelling/ Edema 240 254
Insufficient Information 237 240
Ambulation Difficulties 237 249
Arthralgia 189 192
No Clinical Signs, Symptoms or Conditions 119 120
Arthritis 88 88
Hypersensitivity/Allergic reaction 87 93
Bacterial Infection 57 57
Unspecified Infection 55 55
Rash 50 59
Inflammation 50 52
Loss of Range of Motion 48 51
Cancer 40 42
Peripheral Edema 39 39
Headache 37 39
Synovitis 36 36
Injection Site Reaction 32 32
Erythema 30 30
No Code Available 30 30
Dyspnea 29 29
Nausea 28 31
Itching Sensation 27 32
Fever 26 29
Fatigue 25 25
Muscle Weakness 23 25
Dizziness 21 21
Inadequate Pain Relief 21 23
Thrombosis/Thrombus 19 19
Discomfort 18 18
Sleep Dysfunction 18 19
Myalgia 18 18
Numbness 14 16
Cramp(s) /Muscle Spasm(s) 14 16
Joint Swelling 13 13
Local Reaction 13 14
Myocardial Infarction 13 13
Malaise 13 13
Stroke/CVA 12 12
Necrosis 12 12
Unspecified Tissue Injury 12 12
High Blood Pressure/ Hypertension 11 11
Shaking/Tremors 11 11
Burning Sensation 11 12
Pyogenic Infection 11 11
Therapeutic Response, Decreased 11 11
Arrhythmia 10 10
Fall 10 10
Vomiting 10 10

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