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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
Product CodeMBB
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 3
G21 S.R.L
  SUBSTANTIALLY EQUIVALENT 3
G21 SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 497 497
2020 375 375
2021 648 648
2022 275 275
2023 258 258
2024 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 823 823
Adverse Event Without Identified Device or Use Problem 384 384
Unsealed Device Packaging 335 335
Chemical Problem 148 148
Improper Chemical Reaction 103 103
Loosening of Implant Not Related to Bone-Ingrowth 69 69
Infusion or Flow Problem 55 55
Patient Device Interaction Problem 39 39
Tear, Rip or Hole in Device Packaging 38 38
Device Contaminated During Manufacture or Shipping 32 32
Device Damaged Prior to Use 30 30
Insufficient Information 28 28
Migration 28 28
Appropriate Term/Code Not Available 20 20
Difficult to Open or Remove Packaging Material 19 19
Loss of Osseointegration 15 15
Device Dislodged or Dislocated 13 13
Inaccurate Information 10 10
Expiration Date Error 10 10
Device Ingredient or Reagent Problem 8 8
Material Integrity Problem 8 8
Loose or Intermittent Connection 7 7
Off-Label Use 6 6
Break 6 6
Packaging Problem 6 6
Patient-Device Incompatibility 5 5
Biocompatibility 4 4
Use of Device Problem 4 4
Material Discolored 4 4
Fracture 4 4
Improper or Incorrect Procedure or Method 4 4
Output Problem 3 3
No Apparent Adverse Event 3 3
Coagulation in Device or Device Ingredient 3 3
Mechanical Problem 3 3
Delivered as Unsterile Product 3 3
Migration or Expulsion of Device 2 2
Product Quality Problem 2 2
Fire 2 2
Fluid/Blood Leak 2 2
Unstable 2 2
Device-Device Incompatibility 2 2
Difficult to Open or Close 2 2
Contamination /Decontamination Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Physical Resistance/Sticking 2 2
Missing Information 1 1
Powder Leak 1 1
Material Too Soft/Flexible 1 1
Osseointegration Problem 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1
Naturally Worn 1 1
Material Deformation 1 1
Device Contamination with Chemical or Other Material 1 1
Improper Flow or Infusion 1 1
Detachment of Device or Device Component 1 1
Microbial Contamination of Device 1 1
Partial Blockage 1 1
Failure to Osseointegrate 1 1
Malposition of Device 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Contamination 1 1
Shipping Damage or Problem 1 1
Unintended System Motion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 673 673
No Consequences Or Impact To Patient 440 440
No Code Available 295 295
Insufficient Information 272 272
No Clinical Signs, Symptoms or Conditions 245 245
Adhesion(s) 206 206
Joint Laxity 170 170
Swelling/ Edema 146 146
Unspecified Infection 133 133
Synovitis 93 93
Loss of Range of Motion 91 91
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 79 79
Failure of Implant 68 68
Ambulation Difficulties 63 63
Muscular Rigidity 59 59
Discomfort 55 55
Edema 52 52
Limited Mobility Of The Implanted Joint 41 41
Fall 31 31
Inflammation 25 25
Fatigue 21 21
No Patient Involvement 21 21
Scar Tissue 18 18
Arthralgia 17 17
Joint Disorder 17 17
Weakness 15 15
Hypersensitivity/Allergic reaction 14 14
Cyst(s) 14 14
Unspecified Tissue Injury 14 14
Inadequate Osseointegration 13 13
Thrombosis/Thrombus 13 13
Swelling 13 13
Low Blood Pressure/ Hypotension 13 13
Injury 13 13
Erythema 12 12
Joint Contracture 12 12
Cardiac Arrest 11 11
Wound Dehiscence 10 10
Foreign Body Reaction 10 10
Necrosis 10 10
Implant Pain 10 10
No Known Impact Or Consequence To Patient 9 9
Local Reaction 9 9
Bone Fracture(s) 7 7
Pulmonary Embolism 7 7
Fibrosis 7 7
Bacterial Infection 6 6
Hemorrhage/Bleeding 6 6
Nerve Damage 6 6
Joint Dislocation 6 6
Impaired Healing 5 5
Numbness 5 5
Scarring 5 5
Thrombosis 5 5
No Information 5 5
Muscle/Tendon Damage 5 5
Embolism/Embolus 5 5
Unspecified Musculoskeletal problem 4 4
Not Applicable 4 4
Rash 4 4
Death 4 4
Arthritis 3 3
Ischemia 3 3
Osteolysis 3 3
Osteopenia/ Osteoporosis 3 3
Post Operative Wound Infection 3 3
Confusion/ Disorientation 2 2
Paresthesia 2 2
Physical Asymmetry 2 2
Reaction to Medicinal Component of Device 2 2
Limb Fracture 2 2
Deformity/ Disfigurement 2 2
Hip Fracture 2 2
Discharge 2 2
Neuropathy 2 2
Burning Sensation 2 2
Skin Discoloration 2 2
Myocardial Infarction 2 2
High Blood Pressure/ Hypertension 2 2
Fever 2 2
Non specific EKG/ECG Changes 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Erosion 2 2
Bradycardia 2 2
Abscess 2 2
Ossification 1 1
Arrhythmia 1 1
Infarction, Cerebral 1 1
Fistula 1 1
Intracranial Hemorrhage 1 1
Hematoma 1 1
Nausea 1 1
Tachycardia 1 1
Hot Flashes/Flushes 1 1
Tissue Damage 1 1
Vomiting 1 1
Seroma 1 1
Renal Failure 1 1
Cardiogenic Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Nov-15-2022
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