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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 10

MDR Year MDR Reports MDR Events
2020 441 476
2021 375 399
2022 305 325
2023 470 470
2024 292 292
2025 164 164

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1331 1375
Insufficient Information 117 117
Patient-Device Incompatibility 110 137
Off-Label Use 55 55
Break 39 40
Patient Device Interaction Problem 36 37
Therapeutic or Diagnostic Output Failure 31 32
Use of Device Problem 31 31
Improper or Incorrect Procedure or Method 21 21
Appropriate Term/Code Not Available 17 17
No Apparent Adverse Event 16 16
Microbial Contamination of Device 14 14
Lack of Effect 10 10
Leak/Splash 8 8
Unexpected Therapeutic Results 6 7
Detachment of Device or Device Component 5 9
Fluid/Blood Leak 4 4
Output Problem 4 4
Device Appears to Trigger Rejection 4 5
Device Markings/Labelling Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Failure to Deliver 3 7
Fracture 2 2
Device Contamination with Chemical or Other Material 2 2
Contamination of Device Ingredient or Reagent 2 2
Material Separation 2 2
Product Quality Problem 2 2
Device Handling Problem 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Device Fell 2 2
Device Damaged Prior to Use 2 2
Crack 2 2
Application Program Problem: Medication Error 1 1
Component Missing 1 1
Unintended Ejection 1 1
Misfire 1 1
Shipping Damage or Problem 1 1
Material Integrity Problem 1 1
Expiration Date Error 1 1
Labelling, Instructions for Use or Training Problem 1 1
Migration 1 1
Explosion 1 1
Inaccurate Delivery 1 1
Device Dislodged or Dislocated 1 1
Protective Measures Problem 1 1
Burst Container or Vessel 1 1
Activation, Positioning or Separation Problem 1 1
Nonstandard Device 1 1
Human-Device Interface Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 406 445
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 328 336
Arthralgia 282 285
Ambulation Difficulties 261 280
Swelling/ Edema 253 275
Insufficient Information 249 252
No Code Available 156 156
No Clinical Signs, Symptoms or Conditions 117 118
Hypersensitivity/Allergic reaction 103 111
Arthritis 91 91
Joint Swelling 88 93
Rash 71 82
Inflammation 68 72
Unspecified Infection 64 64
Loss of Range of Motion 63 67
Bacterial Infection 62 63
Swelling 53 58
Synovitis 46 50
Headache 45 51
Erythema 42 44
Peripheral Edema 40 40
Cancer 39 41
Nausea 38 47
Dyspnea 37 41
Itching Sensation 36 43
Fever 35 40
No Known Impact Or Consequence To Patient 35 35
Fatigue 31 31
Injection Site Reaction 31 31
Therapeutic Response, Decreased 30 32
Dizziness 26 27
Muscle Weakness 25 27
Death 25 27
Discomfort 24 24
Sleep Dysfunction 23 24
Myalgia 22 22
Inadequate Pain Relief 21 23
Burning Sensation 20 21
Numbness 20 22
Thrombosis/Thrombus 19 19
Fall 18 18
High Blood Pressure/ Hypertension 17 17
Myocardial Infarction 16 17
Chills 16 23
Necrosis 16 16
Malaise 15 15
Reaction 15 19
Bone Fracture(s) 15 15
Urticaria 15 15
Joint Disorder 15 15

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