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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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
G21 S.R.L
  SUBSTANTIALLY EQUIVALENT 1
G21 S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
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 1293 1293
2021 781 781
2022 472 472
2023 476 476
2024 494 494
2025 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 1446 1446
Adverse Event Without Identified Device or Use Problem 990 990
Loosening of Implant Not Related to Bone-Ingrowth 227 227
Chemical Problem 183 183
Device Damaged Prior to Use 82 82
Unsealed Device Packaging 76 76
Patient Device Interaction Problem 71 71
Migration or Expulsion of Device 68 68
Insufficient Information 56 56
Device Difficult to Setup or Prepare 56 56
Failure to Eject 54 54
Loss of Osseointegration 53 53
Tear, Rip or Hole in Device Packaging 53 53
Migration 48 48
Device Contaminated During Manufacture or Shipping 39 39
Missing Information 36 36
Break 32 32
Unstable 27 27
Fracture 27 27
Improper Chemical Reaction 24 24
Appropriate Term/Code Not Available 24 24
Expiration Date Error 24 24
Fluid/Blood Leak 21 21
Osseointegration Problem 20 20
Difficult to Open or Remove Packaging Material 20 20
Improper or Incorrect Procedure or Method 15 15
Loose or Intermittent Connection 14 14
Noise, Audible 12 12
Off-Label Use 11 11
Failure to Osseointegrate 8 8
No Apparent Adverse Event 7 7
Device Handling Problem 7 7
Use of Device Problem 7 7
Material Integrity Problem 7 7
Defective Device 6 6
Patient-Device Incompatibility 5 5
Coagulation in Device or Device Ingredient 5 5
Contamination /Decontamination Problem 4 4
Device Ingredient or Reagent Problem 4 4
Premature Activation 4 4
Unintended Movement 4 4
Device Dislodged or Dislocated 4 4
Material Fragmentation 3 3
Biocompatibility 3 3
Material Twisted/Bent 3 3
Packaging Problem 3 3
Detachment of Device or Device Component 3 3
Mechanical Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Component Missing 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1362 1362
No Code Available 973 973
No Clinical Signs, Symptoms or Conditions 583 583
Insufficient Information 413 413
Adhesion(s) 322 322
Unspecified Infection 279 279
Swelling/ Edema 259 259
Joint Laxity 233 233
Edema 181 181
Failure of Implant 137 137
Loss of Range of Motion 136 136
Ambulation Difficulties 133 133
Synovitis 130 130
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 118 118
Muscular Rigidity 113 113
Discomfort 96 96
Fall 80 80
Inadequate Osseointegration 74 74
No Consequences Or Impact To Patient 65 65
Limited Mobility Of The Implanted Joint 62 62
Unspecified Tissue Injury 57 57
Osteolysis 49 49
Inflammation 47 47
Pulmonary Embolism 44 44
Injury 38 38
Implant Pain 33 33
Wound Dehiscence 32 32
Necrosis 32 32
Hemorrhage/Bleeding 31 31
Thrombosis/Thrombus 29 29
Cardiac Arrest 27 27
Bone Fracture(s) 25 25
Muscle/Tendon Damage 24 24
Arthralgia 24 24
Hematoma 24 24
Scar Tissue 23 23
Hypersensitivity/Allergic reaction 23 23
Cyst(s) 23 23
No Known Impact Or Consequence To Patient 23 23
Fluid Discharge 21 21
Low Blood Pressure/ Hypotension 20 20
Not Applicable 17 17
Local Reaction 17 17
Fatigue 16 16
Erythema 16 16
Weakness 16 16
Post Operative Wound Infection 16 16
Impaired Healing 16 16
Thrombosis 15 15
Foreign Body Reaction 15 15

Recalls
Manufacturer Recall Class Date Posted
1 BIOPSYBELL S.R.L. II May-19-2021
2 Howmedica Osteonics Corp. III Dec-20-2022
3 Smith & Nephew, Inc. II Jan-29-2021
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