Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
Product CodeLWJ
Regulation Number 888.3360
Device Class 2

MDR Year MDR Reports MDR Events
2019 211 211
2020 189 189
2021 155 155
2022 91 91
2023 72 72
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 135 135
Break 132 132
Insufficient Information 101 101
Device Dislodged or Dislocated 89 89
Fracture 57 57
Loose or Intermittent Connection 47 47
Loss of Osseointegration 28 28
Osseointegration Problem 26 26
Corroded 24 24
Detachment of Device or Device Component 13 13
Appropriate Term/Code Not Available 12 12
Migration 11 11
Material Integrity Problem 10 10
Mechanical Problem 10 10
Degraded 8 8
Difficult to Remove 8 8
Compatibility Problem 8 8
Patient Device Interaction Problem 7 7
Naturally Worn 7 7
No Apparent Adverse Event 7 7
Material Fragmentation 7 7
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Mechanical Jam 5 5
Use of Device Problem 5 5
Biocompatibility 4 4
Physical Resistance/Sticking 4 4
Packaging Problem 3 3
Device Appears to Trigger Rejection 3 3
Unstable 3 3
Malposition of Device 3 3
Device Difficult to Setup or Prepare 3 3
Migration or Expulsion of Device 3 3
Material Disintegration 3 3
Entrapment of Device 2 2
Patient-Device Incompatibility 2 2
Failure to Osseointegrate 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Fell 2 2
Scratched Material 2 2
Noise, Audible 2 2
Measurement System Incompatibility 1 1
Positioning Problem 1 1
Output Problem 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Device-Device Incompatibility 1 1
Material Deformation 1 1
Expulsion 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequacy of Device Shape and/or Size 1 1
Problem with Sterilization 1 1
Unexpected Therapeutic Results 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Defective Device 1 1
Material Erosion 1 1
Collapse 1 1
Component Incompatible 1 1
Positioning Failure 1 1
Material Discolored 1 1
Delivered as Unsterile Product 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 185 185
Pain 87 87
Insufficient Information 73 73
Unspecified Infection 63 63
Bone Fracture(s) 59 59
Failure of Implant 56 56
No Clinical Signs, Symptoms or Conditions 51 51
No Code Available 39 39
Inadequate Osseointegration 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Joint Dislocation 24 24
Metal Related Pathology 20 20
Injury 17 17
Patient Problem/Medical Problem 15 15
Foreign Body Reaction 15 15
Loss of Range of Motion 13 13
Fall 13 13
Osteolysis 13 13
No Known Impact Or Consequence To Patient 11 11
Limb Fracture 11 11
Joint Laxity 11 11
Joint Disorder 9 9
Hip Fracture 9 9
Hypersensitivity/Allergic reaction 9 9
Discomfort 7 7
Foreign Body In Patient 7 7
Reaction 6 6
Inflammation 6 6
Unequal Limb Length 6 6
Bacterial Infection 5 5
Ambulation Difficulties 5 5
Necrosis 5 5
Test Result 4 4
Wound Dehiscence 4 4
Death 4 4
No Consequences Or Impact To Patient 4 4
Unspecified Tissue Injury 4 4
Swelling/ Edema 4 4
Swelling 3 3
Synovitis 3 3
Tissue Damage 3 3
Fatigue 3 3
Ossification 3 3
Fever 2 2
Dyspnea 2 2
Edema 2 2
Hemorrhage/Bleeding 2 2
Limited Mobility Of The Implanted Joint 2 2
Device Embedded In Tissue or Plaque 2 2
Fibrosis 2 2
Distress 2 2
Toxicity 2 2
Blood Loss 2 2
Shaking/Tremors 2 2
Implant Pain 2 2
Thrombosis/Thrombus 2 2
Subluxation 1 1
Reaction to Medicinal Component of Device 1 1
Muscle/Tendon Damage 1 1
Sleep Dysfunction 1 1
No Patient Involvement 1 1
Numbness 1 1
Impaired Healing 1 1
Arthralgia 1 1
Depression 1 1
Non-union Bone Fracture 1 1
Not Applicable 1 1
Paresthesia 1 1
Patch Test, Abnormal Results Of 1 1
Tissue Breakdown 1 1
Osteopenia/ Osteoporosis 1 1
Vascular Dissection 1 1
Keratitis 1 1
Memory Loss/Impairment 1 1
Muscular Rigidity 1 1
Anxiety 1 1
Rash 1 1
Sepsis 1 1
Skin Irritation 1 1
Encephalopathy 1 1
Purulent Discharge 1 1
Hematoma 1 1
Adhesion(s) 1 1
Anemia 1 1
Arrhythmia 1 1
Host-Tissue Reaction 1 1
Erosion 1 1
Cyst(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Jan-31-2024
2 MicroPort Orthopedics Inc. I Sep-18-2020
3 MicroPort Orthopedics Inc. II Sep-09-2020
-
-