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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 1294 1298
2021 782 782
2022 472 473
2023 475 475
2024 492 492
2025 311 311

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 1488 1488
Adverse Event Without Identified Device or Use Problem 1039 1039
Loosening of Implant Not Related to Bone-Ingrowth 236 237
Chemical Problem 211 211
Device Damaged Prior to Use 88 88
Migration or Expulsion of Device 81 81
Patient Device Interaction Problem 78 78
Unsealed Device Packaging 77 77
Failure to Eject 72 72
Device Difficult to Setup or Prepare 62 62
Insufficient Information 62 62
Migration 58 58
Loss of Osseointegration 54 54
Tear, Rip or Hole in Device Packaging 54 54
Device Contaminated During Manufacture or Shipping 44 44
Break 36 36
Fracture 36 37
Missing Information 36 36
Unstable 28 28
Improper Chemical Reaction 24 24
Appropriate Term/Code Not Available 24 27
Expiration Date Error 24 24
Fluid/Blood Leak 23 23
Osseointegration Problem 22 22
Difficult to Open or Remove Packaging Material 20 20
Improper or Incorrect Procedure or Method 17 17
Loose or Intermittent Connection 15 15
Noise, Audible 12 12
Off-Label Use 12 12
No Apparent Adverse Event 12 12
Device Dislodged or Dislocated 9 9
Defective Device 8 8
Use of Device Problem 8 8
Failure to Osseointegrate 8 8
Device Handling Problem 8 8
Material Integrity Problem 7 7
Patient-Device Incompatibility 6 6
Coagulation in Device or Device Ingredient 6 6
Material Fragmentation 5 6
Output Problem 5 5
Unintended Movement 4 4
Device Ingredient or Reagent Problem 4 4
Contamination /Decontamination Problem 4 4
Premature Activation 4 4
Biocompatibility 3 3
Therapeutic or Diagnostic Output Failure 3 3
Shipping Damage or Problem 3 3
Mechanical Problem 3 3
Material Twisted/Bent 3 3
Packaging Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1391 1395
No Code Available 973 973
No Clinical Signs, Symptoms or Conditions 656 656
Insufficient Information 495 495
Adhesion(s) 324 324
Unspecified Infection 293 294
Swelling/ Edema 272 272
Joint Laxity 239 239
Edema 181 181
Failure of Implant 141 143
Loss of Range of Motion 137 137
Ambulation Difficulties 135 135
Synovitis 133 133
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 119 119
Muscular Rigidity 116 116
Discomfort 96 96
Fall 83 83
Inadequate Osseointegration 80 80
No Consequences Or Impact To Patient 65 65
Limited Mobility Of The Implanted Joint 62 62
Unspecified Tissue Injury 61 61
Osteolysis 52 52
Pulmonary Embolism 47 47
Inflammation 46 46
Injury 38 38
Implant Pain 33 33
Wound Dehiscence 32 32
Necrosis 32 32
Hemorrhage/Bleeding 31 31
Bone Fracture(s) 30 30
Thrombosis/Thrombus 29 29
Cardiac Arrest 28 28
Hematoma 27 27
Arthralgia 26 26
Cyst(s) 25 25
Hypersensitivity/Allergic reaction 25 25
Scar Tissue 24 24
Muscle/Tendon Damage 24 24
No Known Impact Or Consequence To Patient 23 23
Low Blood Pressure/ Hypotension 22 22
Fluid Discharge 21 21
Fatigue 18 18
Not Applicable 17 17
Local Reaction 17 17
Weakness 16 16
Post Operative Wound Infection 16 16
Impaired Healing 16 16
Erythema 16 16
Foreign Body Reaction 15 15
Non-union Bone Fracture 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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