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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 8

MDR Year MDR Reports MDR Events
2021 375 399
2022 305 325
2023 470 470
2024 292 292
2025 186 186
2026 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 803 803
Insufficient Device Problem Information 67 67
Break 27 27
No Apparent Adverse Event 15 15
Appropriate Device Problem Term/Code Not Available 14 14
Off-Label Use 13 13
Patient Device Interaction Problem 11 11
Contamination 9 9
Use of Device Problem 7 7
Lack of Effect 7 7
Improper or Incorrect Procedure or Method 6 6
Patient-Device Incompatibility 5 5
Component Missing 2 2
Device Handling Problem 2 2
Leak/Splash 1 1
Expulsion 1 1
Crack 1 1
Device Damaged Prior to Use 1 1
Expiration Date Error 1 1
Material Integrity Problem 1 1
Microbial Contamination of Device 1 1
Contamination /Decontamination Problem 1 1
Fracture 1 1
Device Appears to Trigger Rejection 1 1
Mechanical Jam 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 334 337
Pain 316 337
Swelling/ Edema 254 268
Insufficient Information 247 250
Ambulation or Postural Difficulties 241 253
Arthralgia 190 193
No Clinical Signs, Symptoms or Conditions 120 121
Arthritis 91 91
Hypersensitivity/Allergic reaction 88 94
Bacterial Infection 63 63
Unspecified Infection 55 55
Rash 51 60
Inflammation 50 52
Loss of Range of Motion 49 52
Joint effusion 47 47
Cancer 40 42
Limb Pain 40 40
Peripheral Edema 39 39
Headache 37 39
Synovitis 36 36
Injection Site Reaction 33 33
Erythema 30 30
No Code Available 30 30
Itching Sensation 29 34
Dyspnea 29 29
Nausea 28 31
Fever 27 30
Fatigue 25 25
Muscle Weakness/Atrophy 23 25
Dizziness 21 21
Inadequate Pain Relief 21 23
Sleep Dysfunction 20 21
Thrombosis/Thrombus 19 19
Myalgia 18 18
Discomfort 18 18
Stroke/CVA 16 16
Cramp(s) /Muscle Spasm(s) 16 18
Myocardial Infarction 14 14
Numbness 14 16
Unspecified Tissue Injury 14 14
Necrosis 13 13
Malaise 13 13
Local Reaction 13 14
Joint Swelling 13 13
Atrial Fibrillation 11 12
Pyogenic Infection 11 11
Shaking/Tremors 11 11
Therapeutic Response, Decreased 11 11
Skin Discoloration 11 11
High Blood Pressure/ Hypertension 11 11

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