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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 MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 7
G21 S.R.L
  SUBSTANTIALLY EQUIVALENT 3
G21 SRL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 41 41
2015 20 20
2016 327 327
2017 288 288
2018 330 330
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 895 895
Unsealed Device Packaging 711 711
Adverse Event Without Identified Device or Use Problem 396 396
Infusion or Flow Problem 340 340
Chemical Problem 153 153
Improper Chemical Reaction 150 150
Insufficient Information 94 94
Loosening of Implant Not Related to Bone-Ingrowth 71 71
No Flow 53 53
Tear, Rip or Hole in Device Packaging 51 51
Appropriate Term/Code Not Available 45 45
Patient Device Interaction Problem 39 39
Device Contaminated During Manufacture or Shipping 33 33
Device Damaged Prior to Use 31 31
Migration 28 28
Device Packaging Compromised 19 19
Difficult to Open or Remove Packaging Material 19 19
Loss of Osseointegration 18 18
Device Dislodged or Dislocated 14 14
Material Integrity Problem 13 13
Failure To Adhere Or Bond 12 12
Break 11 11
Migration or Expulsion of Device 11 11
Leak/Splash 10 10
Device Operates Differently Than Expected 10 10
Expiration Date Error 10 10
Inaccurate Information 10 10
Packaging Problem 10 10
Device Ingredient or Reagent Problem 8 8
Loose or Intermittent Connection 8 8
Fracture 6 6
Off-Label Use 6 6
Improper Flow or Infusion 6 6
Missing Value Reason 6 6
Physical Property Issue 5 5
Patient-Device Incompatibility 5 5
Incomplete or Missing Packaging 5 5
Use of Device Problem 5 5
Clumping in Device or Device Ingredient 5 5
Contamination 4 4
Mechanical Problem 4 4
Material Discolored 4 4
Shipping Damage or Problem 4 4
Delivered as Unsterile Product 4 4
Biocompatibility 4 4
Improper or Incorrect Procedure or Method 4 4
Naturally Worn 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Device Handling Problem 4 4
Output Problem 3 3
No Apparent Adverse Event 3 3
Difficult to Open or Close 3 3
Physical Resistance/Sticking 3 3
Unstable 3 3
Fire 3 3
Fluid/Blood Leak 3 3
Coagulation in Device or Device Ingredient 3 3
Crack 2 2
Device Expiration Issue 2 2
Device Emits Odor 2 2
Product Quality Problem 2 2
Precipitate in Device or Device Ingredient 2 2
Malposition of Device 2 2
Device Disinfection Or Sterilization Issue 2 2
Contamination /Decontamination Problem 2 2
Device-Device Incompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 2 2
Therapeutic or Diagnostic Output Failure 2 2
Torn Material 1 1
Activation Failure 1 1
Noise, Audible 1 1
Temperature Problem 1 1
Osseointegration Problem 1 1
Material Too Soft/Flexible 1 1
Missing Information 1 1
Powder Leak 1 1
Human Factors Issue 1 1
Material Deformation 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Failure to Osseointegrate 1 1
Device Slipped 1 1
Sticking 1 1
Inadequate or Insufficient Training 1 1
Material Rupture 1 1
Shelf Life Exceeded 1 1
Unintended System Motion 1 1
Overheating of Device 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Partial Blockage 1 1
Detachment Of Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 936 936
Pain 732 732
No Code Available 333 333
Insufficient Information 274 274
No Clinical Signs, Symptoms or Conditions 245 245
Adhesion(s) 209 209
No Known Impact Or Consequence To Patient 203 203
Joint Laxity 170 170
No Information 169 169
Unspecified Infection 151 151
Swelling/ Edema 146 146
Synovitis 98 98
Loss of Range of Motion 92 92
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 79 79
No Patient Involvement 78 78
Failure of Implant 78 78
Ambulation Difficulties 63 63
Muscular Rigidity 62 62
Discomfort 58 58
Edema 52 52
Limited Mobility Of The Implanted Joint 42 42
Fall 33 33
Inflammation 30 30
Fatigue 21 21
Death 20 20
Cardiac Arrest 18 18
Scar Tissue 18 18
Injury 18 18
Arthralgia 17 17
Joint Disorder 17 17
Swelling 16 16
Weakness 15 15
Hypersensitivity/Allergic reaction 15 15
Not Applicable 15 15
Unspecified Tissue Injury 14 14
Cyst(s) 14 14
Low Blood Pressure/ Hypotension 14 14
Erythema 13 13
Thrombosis/Thrombus 13 13
Inadequate Osseointegration 13 13
Joint Contracture 12 12
Foreign Body Reaction 12 12
Wound Dehiscence 11 11
Necrosis 10 10
Implant Pain 10 10
Local Reaction 9 9
Pulmonary Embolism 8 8
Bone Fracture(s) 8 8
Fibrosis 7 7
Joint Dislocation 7 7
Osteolysis 7 7
Hemorrhage/Bleeding 6 6
Bacterial Infection 6 6
Scarring 6 6
Nerve Damage 6 6
Rash 5 5
Thrombosis 5 5
Impaired Healing 5 5
Reaction 5 5
Numbness 5 5
Embolism/Embolus 5 5
Muscle/Tendon Damage 5 5
Unspecified Musculoskeletal problem 4 4
Post Operative Wound Infection 4 4
Bradycardia 4 4
Arthritis 3 3
High Blood Pressure/ Hypertension 3 3
Ischemia 3 3
Low Oxygen Saturation 3 3
Missing Value Reason 3 3
Osteopenia/ Osteoporosis 3 3
Confusion/ Disorientation 2 2
Vomiting 2 2
Patient Problem/Medical Problem 2 2
Paresthesia 2 2
Sudden Cardiac Death 2 2
Deformity/ Disfigurement 2 2
Physical Asymmetry 2 2
Reaction to Medicinal Component of Device 2 2
Limb Fracture 2 2
Neurological Deficit/Dysfunction 2 2
Neuropathy 2 2
Myocardial Infarction 2 2
Nausea 2 2
Burning Sensation 2 2
Skin Discoloration 2 2
Hip Fracture 2 2
Discharge 2 2
Hematoma 2 2
Fever 2 2
Non specific EKG/ECG Changes 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Erosion 2 2
Abscess 2 2
Ossification 1 1
Arrhythmia 1 1
Infarction, Cerebral 1 1
Cardiopulmonary Arrest 1 1
Fistula 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DePuy Orthopaedics, Inc. II Mar-05-2015
2 DePuy Orthopaedics, Inc. II Oct-23-2013
3 Howmedica Osteonics Corp. II Nov-15-2022
4 Zimmer, Inc. II Jan-13-2014
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