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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone cement, antibiotic
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeMBB
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 325 325
2017 287 287
2018 328 328
2019 465 465
2020 351 351
2021 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 674 674
Infusion or Flow Problem 339 339
Loss of or Failure to Bond 286 286
Adverse Event Without Identified Device or Use Problem 125 125
Improper Chemical Reaction 115 115
Insufficient Information 80 80
No Flow 53 53
Appropriate Term/Code Not Available 39 39
Loosening of Implant Not Related to Bone-Ingrowth 37 37
Chemical Problem 23 23
Tear, Rip or Hole in Device Packaging 18 18
Device Packaging Compromised 17 17
Failure To Adhere Or Bond 12 12
Loss of Osseointegration 11 11
Device Dislodged or Dislocated 11 11
Patient Device Interaction Problem 10 10
Leak/Splash 10 10
Migration or Expulsion of Device 9 9
Break 8 8
Packaging Problem 8 8
Material Integrity Problem 7 7
Improper Flow or Infusion 6 6
Physical Property Issue 5 5
Incomplete or Missing Packaging 5 5
Device Operates Differently Than Expected 5 5
Device Contaminated During Manufacture or Shipping 5 5
Clumping in Device or Device Ingredient 5 5
Contamination 4 4
Delivered as Unsterile Product 4 4
Mechanical Problem 4 4
Missing Value Reason 4 4
Device Handling Problem 3 3
Difficult to Open or Close 3 3
Difficult to Open or Remove Packaging Material 3 3
Fracture 3 3
Use of Device Problem 3 3
Patient-Device Incompatibility 3 3
Shipping Damage or Problem 3 3
Device Damaged Prior to Use 3 3
Contamination /Decontamination Problem 2 2
Device Disinfection Or Sterilization Issue 2 2
Device-Device Incompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Loose or Intermittent Connection 2 2
Material Discolored 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Unstable 2 2
Precipitate in Device or Device Ingredient 2 2
Device Expiration Issue 2 2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 2 2
Naturally Worn 2 2
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Human Factors Issue 1 1
Fire 1 1
Fluid Leak 1 1
Crack 1 1
Overheating of Device 1 1
Shelf Life Exceeded 1 1
Inadequate or Insufficient Training 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1
Difficult to Insert 1 1
Detachment Of Device Component 1 1
Sticking 1 1
Contamination of Device Ingredient or Reagent 1 1
Defective Component 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 934 934
No Code Available 268 268
Pain 260 260
No Known Impact Or Consequence To Patient 196 196
No Information 143 143
No Patient Involvement 75 75
Adhesion(s) 63 63
Unspecified Infection 58 58
Failure of Implant 46 46
Edema 45 45
Limited Mobility Of The Implanted Joint 36 36
Muscular Rigidity 32 32
Discomfort 32 32
Synovitis 26 26
Joint Laxity 26 26
Ambulation Difficulties 26 26
Insufficient Information 26 26
Loss of Range of Motion 24 24
Death 20 20
Swelling/ Edema 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Inflammation 14 14
Fall 14 14
Joint Disorder 14 14
Not Applicable 13 13
Swelling 13 13
Injury 12 12
Cardiac Arrest 12 12
Erythema 11 11
Weakness 10 10
Local Reaction 9 9
Arthralgia 9 9
Cyst(s) 8 8
Fatigue 8 8
Hypersensitivity/Allergic reaction 7 7
No Clinical Signs, Symptoms or Conditions 7 7
Wound Dehiscence 6 6
Thrombosis 5 5
Reaction 5 5
Fibrosis 5 5
Scarring 4 4
Necrosis 4 4
Foreign Body Reaction 4 4
Joint Dislocation 4 4
Osteopenia/ Osteoporosis 3 3
Rash 3 3
Low Blood Pressure/ Hypotension 3 3
Bone Fracture(s) 3 3
Bacterial Infection 3 3
Bradycardia 3 3
Impaired Healing 3 3
Inadequate Osseointegration 3 3
Patient Problem/Medical Problem 2 2
Joint Contracture 2 2
Post Operative Wound Infection 2 2
Hemorrhage/Bleeding 2 2
Skin Discoloration 2 2
Neurological Deficit/Dysfunction 2 2
Pulmonary Embolism 2 2
Arthritis 2 2
Erosion 2 2
Thrombosis/Thrombus 2 2
Low Oxygen Saturation 2 2
Sudden Cardiac Death 2 2
Osteolysis 2 2
Numbness 2 2
Discharge 2 2
Hip Fracture 2 2
Physical Asymmetry 2 2
Hypoesthesia 1 1
Fungal Infection 1 1
Renal Impairment 1 1
Cardiopulmonary Arrest 1 1
Hematoma 1 1
High Blood Pressure/ Hypertension 1 1
Renal Failure 1 1
Hypoxia 1 1
Arrhythmia 1 1
Nausea 1 1
Infarction, Cerebral 1 1
Itching Sensation 1 1
Increased Respiratory Rate 1 1
Joint Swelling 1 1
Depression 1 1
Myalgia 1 1
Anxiety 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Vomiting 1 1
Test Result 1 1
Missing Value Reason 1 1

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