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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 123 123

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 1514 1514
Adverse Event Without Identified Device or Use Problem 1065 1065
Loosening of Implant Not Related to Bone-Ingrowth 238 238
Chemical Problem 224 226
Migration or Expulsion of Device 89 89
Device Damaged Prior to Use 88 88
Failure to Eject 84 84
Patient Device Interaction Problem 76 76
Unsealed Device Packaging 76 76
Device Difficult to Setup or Prepare 62 62
Migration 57 57
Insufficient Device Problem Information 56 56
Tear, Rip or Hole in Device Packaging 56 56
Loss of Osseointegration 55 55
Device Contaminated During Manufacture or Shipping 47 47
Missing Information 36 36
Fracture 35 35
Break 31 32
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
Appropriate Device Problem Term/Code Not Available 15 15
No Apparent Adverse Event 15 15
Improper or Incorrect Procedure or Method 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
Patient-Device Incompatibility 6 6
Device Dislodged or Dislocated 6 6
Material Fragmentation 4 4
Unintended Movement 4 4
Premature Activation 4 4
Use of Device Problem 4 4
Device Ingredient or Reagent Problem 4 4
Packaging Problem 3 3
Material Twisted/Bent 3 3
Detachment of Device or Device Component 3 3
Contamination /Decontamination Problem 3 3
Biocompatibility 3 3
Mechanical Problem 3 3
Loose or Intermittent Connection 3 3
Device-Device Incompatibility 2 2
Component Missing 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1435 1439
No Code Available 973 973
No Clinical Signs, Symptoms or Conditions 702 706
Insufficient Information 525 525
Adhesion(s) 326 326
Unspecified Infection 310 311
Swelling/ Edema 281 281
Joint Laxity 244 244
Edema 181 181
Failure of Implant 144 146
Ambulation or Postural Difficulties 144 144
Loss of Range of Motion 141 141
Synovitis 135 135
Appropriate Clinical Signs, Symptoms and 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 34 34
Necrosis 33 33
Wound Dehiscence 32 32
Bone Fracture(s) 31 31
Hemorrhage/Blood Loss/Bleeding 31 31
Thrombosis/Thrombus 30 30
Cardiac Arrest 30 30
Arthralgia 29 29
Hematoma 27 27
Cyst(s) 27 27
Hypersensitivity/Allergic reaction 25 25
Scar Tissue 25 25
Muscle/Tendon Damage 25 25
Low Blood Pressure/ Hypotension 24 24
Aseptic loosening 24 24
No Known Impact Or Consequence To Patient 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
Nonunion/Delayed-union Bone Fracture 16 16
Deformity/ Disfigurement 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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