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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
  1.  K211869  OGM 1 Polymethylmethacrylate (PMMA) bone cement, O ...
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 477 477
2024 495 495
2025 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 1449 1449
Adverse Event Without Identified Device or Use Problem 1000 1000
Loosening of Implant Not Related to Bone-Ingrowth 229 229
Chemical Problem 187 187
Device Damaged Prior to Use 83 83
Unsealed Device Packaging 76 76
Patient Device Interaction Problem 74 74
Migration or Expulsion of Device 68 68
Failure to Eject 57 57
Insufficient Information 56 56
Device Difficult to Setup or Prepare 56 56
Loss of Osseointegration 53 53
Tear, Rip or Hole in Device Packaging 53 53
Migration 48 48
Device Contaminated During Manufacture or Shipping 41 41
Missing Information 36 36
Break 33 33
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 22 22
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 12 12
Failure to Osseointegrate 8 8
Use of Device Problem 8 8
No Apparent Adverse Event 7 7
Device Handling Problem 7 7
Material Integrity Problem 7 7
Defective Device 7 7
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 1367 1367
No Code Available 973 973
No Clinical Signs, Symptoms or Conditions 591 591
Insufficient Information 422 422
Adhesion(s) 321 321
Unspecified Infection 279 279
Swelling/ Edema 263 263
Joint Laxity 234 234
Edema 181 181
Failure of Implant 139 139
Ambulation Difficulties 136 136
Loss of Range of Motion 136 136
Synovitis 130 130
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 118 118
Muscular Rigidity 114 114
Discomfort 97 97
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 58 58
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
Hematoma 25 25
Bone Fracture(s) 25 25
Cyst(s) 25 25
Arthralgia 25 25
Muscle/Tendon Damage 24 24
Hypersensitivity/Allergic reaction 24 24
Scar Tissue 23 23
No Known Impact Or Consequence To Patient 23 23
Fluid Discharge 21 21
Low Blood Pressure/ Hypotension 21 21
Fatigue 18 18
Not Applicable 17 17
Local Reaction 17 17
Impaired Healing 16 16
Erythema 16 16
Weakness 16 16
Post Operative Wound Infection 16 16
Thrombosis 15 15
Deformity/ Disfigurement 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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