• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device prosthesis, hip, semi-constrained, metal/polymer, uncemented
Regulation Description Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
Product CodeLWJ
Regulation Number 888.3360
Device Class 2

MDR Year MDR Reports MDR Events
2016 297 297
2017 312 312
2018 226 226
2019 211 211
2020 184 184
2021 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Break 347 347
Insufficient Information 299 299
Device Dislodged or Dislocated 139 139
Fracture 91 91
Loose or Intermittent Connection 73 73
Adverse Event Without Identified Device or Use Problem 63 63
Corroded 50 50
Loss of Osseointegration 41 41
Dull, Blunt 36 36
Appropriate Term/Code Not Available 20 20
Material Integrity Problem 19 19
Osseointegration Problem 18 18
Naturally Worn 16 16
Migration or Expulsion of Device 15 15
Metal Shedding Debris 11 11
Difficult to Remove 10 10
Compatibility Problem 10 10
Unstable 10 10
Malposition of Device 7 7
Patient Device Interaction Problem 7 7
Material Fragmentation 6 6
Migration 6 6
Mechanical Problem 5 5
Degraded 5 5
Device Difficult to Setup or Prepare 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Patient-Device Incompatibility 4 4
Material Discolored 4 4
Failure To Adhere Or Bond 4 4
Detachment Of Device Component 3 3
Material Deformation 3 3
Component Missing 3 3
Mechanical Jam 3 3
Device Operates Differently Than Expected 3 3
Use of Device Problem 3 3
Noise, Audible 3 3
Disassembly 3 3
Material Disintegration 3 3
Component Incompatible 2 2
Loss of or Failure to Bond 2 2
Packaging Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Scratched Material 2 2
Physical Resistance/Sticking 2 2
Fitting Problem 2 2
Biocompatibility 2 2
Entrapment of Device 2 2
Material Erosion 1 1
Difficult to Insert 1 1
Biofilm coating in Device 1 1
Device Appears to Trigger Rejection 1 1
Connection Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Positioning Problem 1 1
Material Distortion 1 1
Mechanics Altered 1 1
Device Damaged by Another Device 1 1
Device Issue 1 1
Component or Accessory Incompatibility 1 1
Detachment of Device or Device Component 1 1
Problem with Sterilization 1 1
Nonstandard Device 1 1
Crack 1 1
Collapse 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 529 529
Pain 169 169
Unspecified Infection 109 109
No Known Impact Or Consequence To Patient 89 89
No Code Available 88 88
Reaction 66 66
Bone Fracture(s) 65 65
Injury 53 53
No Consequences Or Impact To Patient 47 47
Joint Dislocation 37 37
Inadequate Osseointegration 36 36
Failure of Implant 22 22
Patient Problem/Medical Problem 18 18
Hip Fracture 14 14
Inflammation 12 12
Insufficient Information 12 12
Osteolysis 11 11
Fall 10 10
Not Applicable 10 10
Joint Disorder 9 9
Death 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
No Clinical Signs, Symptoms or Conditions 7 7
Metal Related Pathology 7 7
Loss of Range of Motion 7 7
Discomfort 7 7
Foreign Body In Patient 7 7
Limited Mobility Of The Implanted Joint 6 6
Tissue Damage 6 6
Ambulation Difficulties 6 6
Swelling 5 5
Rash 5 5
Fatigue 5 5
Test Result 5 5
Missing Value Reason 5 5
No Patient Involvement 4 4
Foreign Body Reaction 4 4
Host-Tissue Reaction 4 4
Hypersensitivity/Allergic reaction 3 3
Toxicity 3 3
Fluid Discharge 3 3
Sleep Dysfunction 3 3
Blood Loss 3 3
Necrosis 3 3
Edema 3 3
Ossification 3 3
Unequal Limb Length 3 3
Limb Fracture 2 2
Joint Laxity 2 2
Weakness 2 2
Device Embedded In Tissue or Plaque 2 2
Synovitis 2 2
Shaking/Tremors 2 2
Infiltration into Tissue 2 2
Hematoma 2 2
Cyst(s) 2 2
Dyspnea 1 1
Encephalopathy 1 1
Arthritis 1 1
Aspiration/Inhalation 1 1
Autoimmune Disorder 1 1
Wound Dehiscence 1 1
Sepsis 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Spinal Column Injury 1 1
Vascular Dissection 1 1
Pericardial Effusion 1 1
Thrombosis/Thrombus 1 1
Skin Tears 1 1
Memory Loss/Impairment 1 1
Paresis 1 1
Rupture 1 1
Reaction to Medicinal Component of Device 1 1
Arthralgia 1 1
Non-union Bone Fracture 1 1
Thyroid Problems 1 1
Patch Test, Abnormal Results Of 1 1
Fibrosis 1 1
Weight Changes 1 1
Burning Sensation 1 1
Anxiety 1 1
Distress 1 1
Nerve Damage 1 1
Scar Tissue 1 1
Scarring 1 1
Adhesion(s) 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Infarction, Cerebral 1 1
Hair Loss 1 1
Hemorrhage/Bleeding 1 1
Implant Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MicroPort Orthopedics Inc. I Sep-18-2020
2 MicroPort Orthopedics Inc. II Sep-09-2020
3 MicroPort Orthopedics Inc. II Aug-18-2016
-
-