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
Regulation Description Polymethylmethacrylate (PMMA) bone cement.
Product CodeLOD
Regulation Number 888.3027
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMECANICA INDUSTRIA E COMERCIODE PRODUTOS ORTOPEDICOS LTDA
  SUBSTANTIALLY EQUIVALENT 1
BIOMET FRANCE
  SUBSTANTIALLY EQUIVALENT 1
G21, S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
HERAEUS MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 4
ORMED GRUP MEDIKAL TURIZM SAGLIK HIZMETLERI SANAYI VE
  SUBSTANTIALLY EQUIVALENT 1
OSARTIS GMBH
  SUBSTANTIALLY EQUIVALENT 3
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 2
TECRES S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1294 1298
2021 782 783
2022 472 474
2023 475 476
2024 491 492
2025 360 360
2026 153 153

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 1525 1525
Adverse Event Without Identified Device or Use Problem 1072 1072
Loosening of Implant Not Related to Bone-Ingrowth 239 239
Chemical Problem 226 228
Migration or Expulsion of Device 91 91
Device Damaged Prior to Use 87 87
Failure to Eject 86 86
Patient Device Interaction Problem 77 77
Unsealed Device Packaging 76 76
Device Difficult to Setup or Prepare 62 62
Migration 57 57
Tear, Rip or Hole in Device Packaging 56 56
Insufficient Device Problem Information 56 56
Loss of Osseointegration 55 55
Device Contaminated During Manufacture or Shipping 47 47
Missing Information 36 36
Fracture 35 35
Break 32 33
Fluid/Blood Leak 24 24
Unstable 24 24
Improper Chemical Reaction 24 24
Expiration Date Error 24 24
Osseointegration Problem 23 23
Difficult to Open or Remove Packaging Material 21 22
Improper or Incorrect Procedure or Method 15 15
Appropriate Device Problem Term/Code Not Available 15 15
No Apparent Adverse Event 15 15
Off-Label Use 12 12
Device Damaged Prior to Receipt by User 11 11
Noise, Audible 10 10
Device Handling Problem 9 9
Failure to Osseointegrate 8 8
Material Integrity Problem 7 7
Coagulation in Device or Device Ingredient 6 6
Device Dislodged or Dislocated 6 6
Patient-Device Incompatibility 6 6
Use of Device Problem 4 4
Material Fragmentation 4 4
Device Ingredient or Reagent Problem 4 4
Unintended Movement 4 4
Premature Activation 4 4
Material Twisted/Bent 3 3
Packaging Problem 3 3
Detachment of Device or Device Component 3 3
Mechanical Problem 3 3
Contamination /Decontamination Problem 3 3
Loose or Intermittent Connection 3 3
Biocompatibility 3 3
Component Missing 2 2
Device-Device Incompatibility 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1439 1443
No Code Available 973 973
No Clinical Signs, Symptoms or Conditions 708 712
Insufficient Information 536 536
Adhesion(s) 327 327
Unspecified Infection 311 312
Swelling/ Edema 281 281
Joint Laxity 245 245
Edema 181 181
Ambulation or Postural Difficulties 144 144
Failure of Implant 144 146
Loss of Range of Motion 142 142
Synovitis 135 135
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 121 121
Muscular Rigidity 118 118
Discomfort 97 97
Fall 88 88
Inadequate Osseointegration 85 85
No Consequences Or Impact To Patient 65 65
Unspecified Tissue Injury 65 65
Limited Mobility Of The Implanted Joint 62 62
Osteolysis 56 56
Inflammation 48 48
Pulmonary Embolism 47 47
Injury 38 38
Implant Pain 34 34
Necrosis 33 33
Wound Dehiscence 32 32
Hemorrhage/Blood Loss/Bleeding 32 32
Bone Fracture(s) 31 31
Cardiac Arrest 30 30
Thrombosis/Thrombus 30 30
Arthralgia 29 29
Cyst(s) 27 27
Hematoma 27 27
Scar Tissue 25 25
Muscle/Tendon Damage 25 25
Hypersensitivity/Allergic reaction 25 25
Low Blood Pressure/ Hypotension 25 25
Aseptic loosening 25 25
No Known Impact Or Consequence To Patient 23 23
Fluid Discharge 23 23
Fatigue 18 18
Not Applicable 17 17
Post Operative Wound Infection 17 17
Erythema 17 17
Local Reaction 17 17
Weakness 16 16
Nonunion/Delayed-union Bone Fracture 16 16
Impaired Healing 16 16

Recalls
Manufacturer Recall Class Date Posted
1 BIOPSYBELL S.R.L. II May-19-2021
2 Heraeus Medical GmbH (Dental Division) II Jan-14-2026
3 Howmedica Osteonics Corp. III Dec-20-2022
4 Smith & Nephew, Inc. II Jan-29-2021
-
-