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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 4
  1.  K150850  Refobacin Bone Cement R
  2.  K160071  StageOne Disposable Cement Spacer Molds for Tempor ...
  3.  K161166  StageOne Select Cement Spacer Molds for Temporary ...
  4.  K161273  StageOne Disposable Cement Spacer Molds for Tempor ...
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2015 18 18
2016 325 325
2017 286 286
2018 322 322
2019 435 435
2020 189 189

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 646 646
Infusion or Flow Problem 339 339
Loss of or Failure to Bond 127 127
Improper Chemical Reaction 112 112
Insufficient Information 80 80
Adverse Event Without Identified Device or Use Problem 70 70
No Flow 53 53
Appropriate Term/Code Not Available 41 41
Loosening of Implant Not Related to Bone-Ingrowth 21 21
Device Packaging Compromised 19 19
Tear, Rip or Hole in Device Packaging 17 17
Chemical Problem 13 13
Failure To Adhere Or Bond 12 12
Loss of Osseointegration 11 11
Device Dislodged or Dislocated 11 11
Device Operates Differently Than Expected 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
Missing Value Reason 6 6
Physical Property Issue 5 5
Incomplete or Missing Packaging 5 5
Clumping in Device or Device Ingredient 5 5
Contamination 4 4
Delivered as Unsterile Product 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Shipping Damage or Problem 4 4
Mechanical Problem 4 4
Naturally Worn 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
Device Contaminated During Manufacture or Shipping 3 3
Unstable 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
Precipitate in Device or Device Ingredient 2 2
Device Expiration Issue 2 2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 2 2
Patient Device Interaction Problem 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
Device Emits Odor 1 1
Overheating of Device 1 1
Shelf Life Exceeded 1 1
Device Slipped 1 1
Inadequate or Insufficient Training 1 1
Patient-Device Incompatibility 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
Material Deformation 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 903 903
No Known Impact Or Consequence To Patient 202 202
No Code Available 164 164
No Information 149 149
Pain 124 124
No Patient Involvement 69 69
Unspecified Infection 53 53
Failure of Implant 37 37
Edema 29 29
Adhesion(s) 21 21
Limited Mobility Of The Implanted Joint 21 21
Death 20 20
Discomfort 17 17
Ambulation Difficulties 16 16
Injury 13 13
Joint Disorder 11 11
Muscular Rigidity 11 11
Synovitis 11 11
Erythema 11 11
Loss of Range of Motion 10 10
Cardiac Arrest 9 9
Not Applicable 9 9
Inflammation 8 8
Swelling 8 8
Thrombosis 5 5
Fall 5 5
Reaction 5 5
Joint Dislocation 4 4
Cyst(s) 3 3
Rash 3 3
Impaired Healing 3 3
Inadequate Osseointegration 3 3
Weakness 3 3
Bone Fracture(s) 3 3
Fibrosis 3 3
Missing Value Reason 3 3
Foreign Body Reaction 2 2
Bradycardia 2 2
Scarring 2 2
Patient Problem/Medical Problem 2 2
Post Operative Wound Infection 2 2
Neurological Deficit/Dysfunction 2 2
Discharge 2 2
Pulmonary Embolism 2 2
Arthritis 2 2
Osteolysis 2 2
Low Oxygen Saturation 2 2
Sudden Cardiac Death 2 2
Fungal Infection 1 1
Osteopenia/ Osteoporosis 1 1
Renal Impairment 1 1
Cardiopulmonary Arrest 1 1
Wound Dehiscence 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hip Fracture 1 1
Renal Failure 1 1
Increased Respiratory Rate 1 1
Test Result 1 1
Myalgia 1 1
Anxiety 1 1
Joint Swelling 1 1
Depression 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Hypoxia 1 1
Tissue Damage 1 1
Urinary Retention 1 1
Vomiting 1 1
Nausea 1 1
Necrosis 1 1
Itching Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Mar-05-2015
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