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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 259 259
2024 138 143

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 844 844
Adverse Event Without Identified Device or Use Problem 420 420
Unsealed Device Packaging 335 335
Chemical Problem 151 151
Improper Chemical Reaction 103 103
Loosening of Implant Not Related to Bone-Ingrowth 80 85
Infusion or Flow Problem 55 55
Patient Device Interaction Problem 40 40
Tear, Rip or Hole in Device Packaging 39 39
Device Damaged Prior to Use 35 35
Device Contaminated During Manufacture or Shipping 32 32
Migration 30 30
Insufficient Information 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 14 14
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
Break 6 6
Off-Label Use 6 6
Packaging Problem 6 6
Fracture 5 5
Biocompatibility 5 5
Patient-Device Incompatibility 5 5
Improper or Incorrect Procedure or Method 4 4
Use of Device Problem 4 4
Material Discolored 4 4
Coagulation in Device or Device Ingredient 4 4
Output Problem 3 3
Delivered as Unsterile Product 3 3
Mechanical Problem 3 3
Fluid/Blood Leak 3 3
No Apparent Adverse Event 3 3
Product Quality Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Migration or Expulsion of Device 2 2
Unstable 2 2
Device-Device Incompatibility 2 2
Contamination /Decontamination Problem 2 2
Physical Resistance/Sticking 2 2
Fire 2 2
Difficult to Open or Close 2 2
Failure to Osseointegrate 2 2
Unintended System Motion 1 1
Material Too Soft/Flexible 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 706 706
No Consequences Or Impact To Patient 440 440
No Code Available 295 295
Insufficient Information 284 284
No Clinical Signs, Symptoms or Conditions 253 253
Adhesion(s) 210 210
Joint Laxity 176 176
Swelling/ Edema 151 151
Unspecified Infection 144 144
Synovitis 95 95
Loss of Range of Motion 92 92
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 80 80
Failure of Implant 76 81
Ambulation Difficulties 68 68
Muscular Rigidity 59 59
Discomfort 57 57
Edema 52 52
Limited Mobility Of The Implanted Joint 41 41
Fall 33 33
Inflammation 25 25
No Patient Involvement 21 21
Fatigue 21 21
Arthralgia 19 19
Scar Tissue 18 18
Joint Disorder 17 17
Hypersensitivity/Allergic reaction 15 15
Inadequate Osseointegration 15 15
Weakness 15 15
Unspecified Tissue Injury 14 14
Cyst(s) 14 14
Low Blood Pressure/ Hypotension 13 13
Swelling 13 13
Thrombosis/Thrombus 13 13
Injury 13 13
Erythema 12 12
Joint Contracture 12 12
Implant Pain 11 11
Cardiac Arrest 11 11
Necrosis 10 10
Foreign Body Reaction 10 10
Wound Dehiscence 10 10
Bone Fracture(s) 9 9
Local Reaction 9 9
No Known Impact Or Consequence To Patient 9 9
Joint Dislocation 7 7
Fibrosis 7 7
Pulmonary Embolism 7 7
Muscle/Tendon Damage 6 6
Bacterial Infection 6 6
Hemorrhage/Bleeding 6 6

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