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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device 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 2
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 5
OSTEOREMEDIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
TECRES S.P.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2303 2303
2020 1293 1293
2021 781 781
2022 471 471
2023 477 477
2024 150 150

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 2895 2895
Adverse Event Without Identified Device or Use Problem 1226 1226
Loosening of Implant Not Related to Bone-Ingrowth 349 349
Chemical Problem 186 186
Unsealed Device Packaging 147 147
Loss of Osseointegration 110 110
Device Damaged Prior to Use 81 81
Insufficient Information 76 76
Appropriate Term/Code Not Available 71 71
Patient Device Interaction Problem 66 66
Tear, Rip or Hole in Device Packaging 63 63
Device Difficult to Setup or Prepare 62 62
Migration 60 60
Migration or Expulsion of Device 59 59
Loose or Intermittent Connection 51 51
Failure to Eject 42 42
Device Contaminated During Manufacture or Shipping 40 40
Break 35 35
Unstable 34 34
Fracture 31 31
Improper Chemical Reaction 29 29
Expiration Date Error 29 29
Packaging Problem 29 29
Osseointegration Problem 24 24
Fluid/Blood Leak 22 22
Improper or Incorrect Procedure or Method 16 16
Difficult to Open or Remove Packaging Material 13 13
Noise, Audible 13 13
Off-Label Use 12 12
Material Integrity Problem 11 11
Missing Information 11 11
No Apparent Adverse Event 10 10
Failure to Osseointegrate 10 10
Use of Device Problem 9 9
Mechanical Problem 8 8
Contamination /Decontamination Problem 8 8
Device Handling Problem 8 8
Unintended Movement 7 7
Defective Device 7 7
Delivered as Unsterile Product 7 7
Product Quality Problem 5 5
Coagulation in Device or Device Ingredient 5 5
Patient-Device Incompatibility 5 5
Incomplete or Missing Packaging 5 5
Device Dislodged or Dislocated 4 4
Device Ingredient or Reagent Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Activation Problem 3 3
Material Twisted/Bent 3 3
Detachment of Device or Device Component 3 3
Naturally Worn 3 3
Biocompatibility 3 3
Material Discolored 3 3
Material Fragmentation 3 3
Difficult to Insert 2 2
Leak/Splash 2 2
Contamination 2 2
Crack 2 2
Entrapment of Device 2 2
Material Erosion 2 2
Fire 2 2
Clumping in Device or Device Ingredient 2 2
Unintended System Motion 2 2
Premature Activation 2 2
Defective Component 2 2
Component Missing 2 2
Output Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Deformation 2 2
Compatibility Problem 2 2
Material Split, Cut or Torn 2 2
Ejection Problem 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Non Reproducible Results 1 1
Device Difficult to Maintain 1 1
Temperature Problem 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
Device Markings/Labelling Problem 1 1
Device-Device Incompatibility 1 1
Mechanical Jam 1 1
Inaccurate Delivery 1 1
Activation, Positioning or Separation Problem 1 1
Malposition of Device 1 1
Fumes or Vapors 1 1
Peeled/Delaminated 1 1
Misassembled 1 1
Nonstandard Device 1 1
Difficult to Remove 1 1
Material Too Rigid or Stiff 1 1
Problem with Sterilization 1 1
Unexpected Therapeutic Results 1 1
Material Puncture/Hole 1 1
Computer Software Problem 1 1
Degraded 1 1
Failure to Back-Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2826 2826
Pain 2473 2473
Adhesion(s) 480 480
No Clinical Signs, Symptoms or Conditions 459 459
Edema 422 422
Unspecified Infection 403 403
Insufficient Information 327 327
No Consequences Or Impact To Patient 277 277
Swelling/ Edema 242 242
Joint Laxity 223 223
Loss of Range of Motion 175 175
Synovitis 168 168
Limited Mobility Of The Implanted Joint 155 155
Discomfort 142 142
Muscular Rigidity 140 140
Ambulation Difficulties 134 134
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 120 120
Failure of Implant 119 119
Swelling 109 109
Injury 101 101
Fall 86 86
Inflammation 84 84
Inadequate Osseointegration 73 73
Osteolysis 72 72
Joint Disorder 53 53
No Known Impact Or Consequence To Patient 52 52
Not Applicable 52 52
Fibrosis 51 51
Hypersensitivity/Allergic reaction 48 48
Unspecified Tissue Injury 47 47
Scar Tissue 46 46
Pulmonary Embolism 44 44
Tissue Damage 43 43
Wound Dehiscence 37 37
Necrosis 36 36
Scarring 34 34
Hematoma 33 33
Hemorrhage/Bleeding 33 33
Cardiac Arrest 31 31
Thrombosis 31 31
Weakness 28 28
Cyst(s) 27 27
Implant Pain 26 26
Bone Fracture(s) 25 25
No Information 24 24
Local Reaction 23 23
Thrombosis/Thrombus 22 22
Arthralgia 20 20
Fatigue 20 20
Erythema 19 19
Muscle/Tendon Damage 19 19
Low Blood Pressure/ Hypotension 18 18
Foreign Body Reaction 18 18
Deformity/ Disfigurement 18 18
Post Operative Wound Infection 16 16
Fluid Discharge 16 16
Impaired Healing 14 14
Sepsis 14 14
Nerve Damage 13 13
Non-union Bone Fracture 11 11
Fever 10 10
Death 10 10
Hypoesthesia 9 9
No Patient Involvement 9 9
Cellulitis 8 8
Abscess 8 8
Ossification 7 7
Pulmonary Edema 7 7
Myocardial Infarction 7 7
Blood Loss 7 7
Numbness 7 7
Perforation of Vessels 7 7
Anxiety 7 7
Reaction 6 6
Limb Fracture 6 6
Embolism/Embolus 6 6
Pocket Erosion 6 6
Anemia 6 6
Erosion 6 6
Arthritis 6 6
Unspecified Musculoskeletal problem 6 6
Bacterial Infection 5 5
Dyspnea 5 5
Purulent Discharge 5 5
Stroke/CVA 5 5
Infarction, Cerebral 5 5
Rash 5 5
Joint Dislocation 5 5
Osteopenia/ Osteoporosis 4 4
Patient Problem/Medical Problem 4 4
Cerebrospinal Fluid Leakage 4 4
Joint Contracture 4 4
Metal Related Pathology 4 4
Renal Impairment 3 3
Malunion of Bone 3 3
Chest Pain 3 3
Pneumonia 3 3
Paralysis 3 3
Nausea 3 3
Test Result 3 3

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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