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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
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 492 493
2025 360 360
2026 109 109

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 1513 1513
Adverse Event Without Identified Device or Use Problem 1085 1085
Loosening of Implant Not Related to Bone-Ingrowth 248 249
Chemical Problem 223 225
Migration or Expulsion of Device 88 88
Device Damaged Prior to Use 88 88
Patient Device Interaction Problem 84 84
Failure to Eject 83 83
Unsealed Device Packaging 77 77
Insufficient Information 69 69
Device Difficult to Setup or Prepare 62 62
Migration 58 58
Tear, Rip or Hole in Device Packaging 56 56
Loss of Osseointegration 55 55
Device Contaminated During Manufacture or Shipping 45 45
Fracture 39 40
Break 37 38
Missing Information 36 36
Unstable 28 28
Fluid/Blood Leak 27 27
Improper Chemical Reaction 24 24
Appropriate Term/Code Not Available 24 27
Expiration Date Error 24 24
Osseointegration Problem 23 23
Difficult to Open or Remove Packaging Material 21 22
Improper or Incorrect Procedure or Method 18 18
Loose or Intermittent Connection 17 17
No Apparent Adverse Event 15 15
Noise, Audible 12 12
Off-Label Use 12 12
Shipping Damage or Problem 11 11
Use of Device Problem 11 11
Patient-Device Incompatibility 9 9
Device Handling Problem 9 9
Device Dislodged or Dislocated 9 9
Defective Device 8 8
Material Integrity Problem 8 8
Failure to Osseointegrate 8 8
Output Problem 7 7
Coagulation in Device or Device Ingredient 6 6
Therapeutic or Diagnostic Output Failure 5 5
Material Fragmentation 5 6
Unintended Movement 4 4
Device Ingredient or Reagent Problem 4 4
Contamination /Decontamination Problem 4 4
Premature Activation 4 4
Biocompatibility 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 1433 1437
No Code Available 973 973
No Clinical Signs, Symptoms or Conditions 698 702
Insufficient Information 521 521
Adhesion(s) 326 326
Unspecified Infection 308 309
Swelling/ Edema 281 281
Joint Laxity 243 243
Edema 181 181
Failure of Implant 144 146
Ambulation Difficulties 142 142
Loss of Range of Motion 141 141
Synovitis 135 135
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 121 121
Muscular Rigidity 117 117
Discomfort 97 97
Fall 88 88
Inadequate Osseointegration 85 85
No Consequences Or Impact To Patient 65 65
Unspecified Tissue Injury 64 64
Limited Mobility Of The Implanted Joint 62 62
Osteolysis 56 56
Inflammation 48 48
Pulmonary Embolism 47 47
Injury 38 38
Implant Pain 33 33
Necrosis 33 33
Wound Dehiscence 32 32
Hemorrhage/Bleeding 31 31
Bone Fracture(s) 31 31
Cardiac Arrest 30 30
Thrombosis/Thrombus 30 30
Arthralgia 29 29
Hematoma 27 27
Cyst(s) 27 27
Scar Tissue 25 25
Muscle/Tendon Damage 25 25
Hypersensitivity/Allergic reaction 25 25
No Known Impact Or Consequence To Patient 23 23
Low Blood Pressure/ Hypotension 23 23
Fluid Discharge 22 22
Fatigue 18 18
Erythema 17 17
Not Applicable 17 17
Local Reaction 17 17
Post Operative Wound Infection 17 17
Deformity/ Disfigurement 16 16
Non-union Bone Fracture 16 16
Weakness 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
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