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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, femoral component, cemented, metal
Product CodeJDG
Regulation Number 888.3360
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 328 328
2018 452 452
2019 336 336
2020 1046 1046
2021 1209 1209
2022 854 854

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1670 1670
Insufficient Information 440 440
Adverse Event Without Identified Device or Use Problem 348 348
Fracture 236 236
Material Twisted/Bent 209 209
Crack 190 190
Material Deformation 160 160
Naturally Worn 135 135
Device Dislodged or Dislocated 127 127
Connection Problem 98 98
Defective Device 73 73
Material Fragmentation 64 64
Appropriate Term/Code Not Available 62 62
Corroded 56 56
Loose or Intermittent Connection 53 53
Mechanical Problem 50 50
Detachment of Device or Device Component 50 50
Unstable 42 42
Incomplete or Inadequate Connection 41 41
Dull, Blunt 38 38
Mechanics Altered 35 35
Biocompatibility 34 34
Mechanical Jam 29 29
Degraded 27 27
Flaked 26 26
Migration or Expulsion of Device 25 25
Loss of Osseointegration 23 23
Material Erosion 22 22
Material Separation 18 18
Loosening of Implant Not Related to Bone-Ingrowth 18 18
Migration 18 18
Scratched Material 17 17
Component Missing 16 16
Peeled/Delaminated 16 16
Noise, Audible 16 16
Physical Resistance/Sticking 15 15
Material Disintegration 15 15
Loss of or Failure to Bond 14 14
Malposition of Device 11 11
Metal Shedding Debris 10 10
Inadequacy of Device Shape and/or Size 9 9
Activation, Positioning or Separation Problem 8 8
Failure to Align 7 7
Nonstandard Device 7 7
Premature Separation 7 7
Solder Joint Fracture 6 6
Deformation Due to Compressive Stress 6 6
Separation Failure 5 5
Positioning Problem 5 5
Material Integrity Problem 5 5
Positioning Failure 5 5
Difficult or Delayed Separation 5 5
Sharp Edges 4 4
Material Split, Cut or Torn 4 4
Failure To Adhere Or Bond 4 4
Misconnection 4 4
Difficult to Insert 4 4
Fitting Problem 4 4
Device Damaged Prior to Use 4 4
Defective Component 4 4
Osseointegration Problem 4 4
No Apparent Adverse Event 4 4
Unintended Movement 3 3
Problem with Sterilization 3 3
Use of Device Problem 3 3
Difficult to Remove 3 3
Patient Device Interaction Problem 3 3
Failure to Clean Adequately 3 3
Device Handling Problem 2 2
Device Fell 2 2
Off-Label Use 2 2
Device Appears to Trigger Rejection 2 2
Difficult to Open or Close 2 2
Device Damaged by Another Device 2 2
Incomplete Coaptation 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device-Device Incompatibility 1 1
Failure to Reset 1 1
Device Slipped 1 1
Failure to Osseointegrate 1 1
Improper or Incorrect Procedure or Method 1 1
Component Incompatible 1 1
Contamination 1 1
Disconnection 1 1
Misassembled 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2172 2172
No Known Impact Or Consequence To Patient 374 374
Pain 296 296
No Patient Involvement 238 238
Injury 217 217
No Consequences Or Impact To Patient 216 216
No Information 205 205
No Code Available 194 194
Joint Dislocation 147 147
Unspecified Infection 137 137
Failure of Implant 81 81
Inflammation 74 74
Reaction 68 68
Tissue Damage 66 66
Test Result 64 64
Bone Fracture(s) 62 62
Not Applicable 61 61
Insufficient Information 54 54
Osteolysis 48 48
Discomfort 43 43
Inadequate Osseointegration 37 37
Foreign Body Reaction 34 34
Metal Related Pathology 30 30
Limited Mobility Of The Implanted Joint 29 29
Foreign Body In Patient 23 23
Loss of Range of Motion 21 21
Ambulation Difficulties 17 17
Deformity/ Disfigurement 15 15
Swelling 14 14
Host-Tissue Reaction 13 13
Fall 12 12
Bacterial Infection 10 10
Hip Fracture 10 10
Death 9 9
Blood Loss 9 9
Thrombosis/Thrombus 9 9
Hypersensitivity/Allergic reaction 8 8
Local Reaction 8 8
Distress 7 7
Necrosis 7 7
Impaired Healing 7 7
Post Operative Wound Infection 6 6
Nerve Damage 6 6
Thrombosis 6 6
Depression 5 5
Joint Swelling 5 5
Hematoma 5 5
Fatigue 5 5
Wound Dehiscence 5 5
Ossification 5 5
Non-union Bone Fracture 5 5
Device Embedded In Tissue or Plaque 5 5
Subluxation 5 5
Confusion/ Disorientation 4 4
Weakness 4 4
Synovitis 4 4
Perforation 4 4
Scar Tissue 4 4
Scarring 3 3
Toxicity 3 3
Peroneal Nerve Palsy 3 3
Edema 3 3
Infiltration into Tissue 3 3
Cyst(s) 3 3
Muscular Rigidity 3 3
Joint Disorder 3 3
Fluid Discharge 3 3
Unequal Limb Length 3 3
Malunion of Bone 3 3
Swelling/ Edema 3 3
Joint Laxity 2 2
Muscle/Tendon Damage 2 2
Patient Problem/Medical Problem 2 2
Balance Problems 2 2
Osteopenia/ Osteoporosis 2 2
Muscle Weakness 2 2
Cellulitis 2 2
Infarction, Cerebral 2 2
Arthritis 2 2
Dizziness 2 2
Nausea 2 2
Rupture 2 2
Urinary Tract Infection 2 2
Vertigo 1 1
Transient Ischemic Attack 1 1
Thyroid Problems 1 1
Renal Failure 1 1
Respiratory Distress 1 1
Myalgia 1 1
Toxoplasmosis, Acquired 1 1
Ulcer 1 1
Anxiety 1 1
Hypoesthesia 1 1
Complaint, Ill-Defined 1 1
Erosion 1 1
Cardiac Arrest 1 1
Pulmonary Embolism 1 1
Abscess 1 1
Adhesion(s) 1 1
Anemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Feb-17-2022
2 Howmedica Osteonics Corp. II Nov-30-2021
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