Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device bone cement, antibiotic
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeMBB
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 3
G21, S.R.L.
  SUBSTANTIALLY EQUIVALENT 5
OSARTIS GMBH
  SUBSTANTIALLY EQUIVALENT 1
TEKNIMED SAS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 497 515
2020 375 388
2021 649 650
2022 275 282
2023 262 265
2024 212 220
2025 175 175
2026 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 933 960
Adverse Event Without Identified Device or Use Problem 486 497
Unsealed Device Packaging 334 334
Chemical Problem 209 211
Improper Chemical Reaction 103 104
Loosening of Implant Not Related to Bone-Ingrowth 97 110
Infusion or Flow Problem 55 55
Device Damaged Prior to Use 54 54
Device Contaminated During Manufacture or Shipping 51 51
Tear, Rip or Hole in Device Packaging 47 47
Patient Device Interaction Problem 45 45
Migration 32 32
Insufficient Device Problem Information 30 30
Device Damaged Prior to Receipt by User 24 24
Difficult to Open or Remove Packaging Material 24 24
Loss of Osseointegration 19 20
Device Dislodged or Dislocated 14 14
Appropriate Device Problem Term/Code Not Available 13 13
Expiration Date Error 11 12
Inaccurate Information 10 10
Device Ingredient or Reagent Problem 8 8
Loose or Intermittent Connection 7 12
Off-Label Use 7 7
Patient-Device Incompatibility 7 7
Fluid/Blood Leak 7 7
Packaging Problem 6 6
Fracture 6 7
No Apparent Adverse Event 5 6
Material Integrity Problem 5 5
Biocompatibility 5 5
Coagulation in Device or Device Ingredient 5 5
Break 5 5
Delivered as Unsterile Product 5 5
Improper or Incorrect Procedure or Method 5 5
Material Discolored 4 4
Device Markings/Labelling Problem 4 4
Use of Device Problem 4 4
Mechanical Problem 3 3
Osseointegration Problem 3 3
Fire 2 2
Material Fragmentation 2 2
Contamination /Decontamination Problem 2 2
Device-Device Incompatibility 2 2
Difficult to Open or Close 2 2
Migration or Expulsion of Device 2 2
Powder Leak 2 2
Output Problem 2 2
Noise, Audible 2 2
Failure to Osseointegrate 2 2
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 779 810
No Consequences Or Impact To Patient 440 440
No Clinical Signs, Symptoms or Conditions 371 374
Insufficient Information 362 362
No Code Available 295 326
Adhesion(s) 220 224
Joint Laxity 196 205
Unspecified Infection 174 174
Swelling/ Edema 173 183
Synovitis 111 114
Loss of Range of Motion 105 107
Failure of Implant 87 99
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 82 82
Ambulation or Postural Difficulties 82 87
Muscular Rigidity 67 71
Discomfort 59 68
Edema 52 57
Limited Mobility Of The Implanted Joint 41 52
Fall 37 37
Inflammation 26 26
Inadequate Osseointegration 22 22
Fatigue 22 27
Arthralgia 21 21
Scar Tissue 21 21
No Patient Involvement 21 21
Unspecified Tissue Injury 20 20
Cardiac Arrest 17 17
Joint Disorder 17 21
Low Blood Pressure/ Hypotension 17 17
Hypersensitivity/Allergic reaction 16 18
Weakness 15 20
Erythema 14 14
Thrombosis/Thrombus 14 14
Cyst(s) 14 14
Osteolysis 13 15
Implant Pain 13 13
Injury 13 15
Swelling 13 14
Joint Contracture 12 12
Foreign Body Reaction 12 12
Bone Cement Implantation Syndrome 11 11
Joint Dislocation 11 11
Bone Fracture(s) 11 12
Wound Dehiscence 10 10
Necrosis 10 10
No Known Impact Or Consequence To Patient 9 9
Aseptic loosening 9 9
Pulmonary Embolism 9 9
Local Reaction 9 9
Embolism/Embolus 9 9

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