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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 341 341

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 2927 2927
Adverse Event Without Identified Device or Use Problem 1282 1282
Loosening of Implant Not Related to Bone-Ingrowth 356 356
Chemical Problem 203 203
Unsealed Device Packaging 147 147
Loss of Osseointegration 110 110
Device Damaged Prior to Use 99 99
Insufficient Information 77 77
Appropriate Term/Code Not Available 71 71
Patient Device Interaction Problem 68 68
Migration or Expulsion of Device 66 66
Device Difficult to Setup or Prepare 65 65
Tear, Rip or Hole in Device Packaging 65 65
Migration 64 64
Loose or Intermittent Connection 51 51
Failure to Eject 47 47
Missing Information 44 44
Device Contaminated During Manufacture or Shipping 40 40
Break 38 38
Unstable 35 35
Fracture 33 33
Packaging Problem 29 29
Improper Chemical Reaction 29 29
Expiration Date Error 29 29
Osseointegration Problem 24 24
Fluid/Blood Leak 23 23
Difficult to Open or Remove Packaging Material 22 22
Improper or Incorrect Procedure or Method 16 16
Noise, Audible 14 14
Off-Label Use 12 12
Material Integrity Problem 11 11
Failure to Osseointegrate 10 10
No Apparent Adverse Event 10 10
Use of Device Problem 9 9
Contamination /Decontamination Problem 8 8
Device Handling Problem 8 8
Mechanical Problem 8 8
Unintended Movement 7 7
Defective Device 7 7
Delivered as Unsterile Product 7 7
Patient-Device Incompatibility 5 5
Coagulation in Device or Device Ingredient 5 5
Product Quality Problem 5 5
Incomplete or Missing Packaging 5 5
Device Dislodged or Dislocated 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Fragmentation 4 4
Premature Activation 4 4
Device Ingredient or Reagent Problem 4 4
Detachment of Device or Device Component 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2826 2826
Pain 2501 2501
No Clinical Signs, Symptoms or Conditions 530 530
Adhesion(s) 484 484
Unspecified Infection 425 425
Edema 422 422
Insufficient Information 371 371
No Consequences Or Impact To Patient 277 277
Swelling/ Edema 250 250
Joint Laxity 235 235
Loss of Range of Motion 182 182
Synovitis 170 170
Limited Mobility Of The Implanted Joint 155 155
Discomfort 146 146
Muscular Rigidity 141 141
Ambulation Difficulties 139 139
Failure of Implant 128 128
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 120 120
Swelling 109 109
Injury 101 101
Fall 89 89
Inflammation 84 84
Osteolysis 74 74
Inadequate Osseointegration 73 73
Joint Disorder 53 53
No Known Impact Or Consequence To Patient 52 52
Not Applicable 52 52
Fibrosis 51 51
Unspecified Tissue Injury 51 51
Hypersensitivity/Allergic reaction 49 49
Scar Tissue 48 48
Pulmonary Embolism 46 46
Tissue Damage 43 43
Wound Dehiscence 40 40
Necrosis 38 38
Hematoma 37 37
Hemorrhage/Bleeding 34 34
Scarring 34 34
Cardiac Arrest 32 32
Thrombosis 31 31
Implant Pain 31 31
Weakness 28 28
Cyst(s) 28 28
Bone Fracture(s) 28 28
Thrombosis/Thrombus 25 25
No Information 24 24
Local Reaction 23 23
Arthralgia 22 22
Fatigue 20 20
Erythema 20 20

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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