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/ceramic/ceramic/metal, cemented or uncemented
Product CodeMRA
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
17 13 18 33 19 6

MDR Year MDR Reports MDR Events
2019 641 641
2020 371 371
2021 109 109
2022 89 89
2023 134 134
2024 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Break 637 637
Adverse Event Without Identified Device or Use Problem 213 213
Fracture 179 179
Material Twisted/Bent 56 56
Device Dislodged or Dislocated 55 55
Insufficient Information 54 54
Noise, Audible 45 45
Naturally Worn 38 38
Material Deformation 32 32
Loosening of Implant Not Related to Bone-Ingrowth 25 25
Scratched Material 22 22
Crack 20 20
Device-Device Incompatibility 19 19
Loss of Osseointegration 17 17
Degraded 14 14
Osseointegration Problem 14 14
Difficult to Insert 11 11
Malposition of Device 11 11
Patient Device Interaction Problem 10 10
Appropriate Term/Code Not Available 9 9
Use of Device Problem 9 9
Biocompatibility 7 7
Loose or Intermittent Connection 7 7
Migration 7 7
Detachment of Device or Device Component 7 7
Physical Resistance/Sticking 6 6
Unstable 6 6
Failure to Osseointegrate 5 5
Connection Problem 5 5
Difficult to Remove 5 5
Positioning Failure 5 5
Corroded 5 5
Unintended Movement 5 5
Unsealed Device Packaging 4 4
Device Slipped 4 4
Component Missing 3 3
Inadequacy of Device Shape and/or Size 3 3
Mechanical Problem 3 3
Material Fragmentation 3 3
Mechanical Jam 3 3
Packaging Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Frayed 2 2
Loss of or Failure to Bond 2 2
Material Erosion 2 2
Material Disintegration 2 2
Patient-Device Incompatibility 2 2
Fitting Problem 2 2
Device Damaged Prior to Use 1 1
Ambient Noise Problem 1 1
Contamination /Decontamination Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Advance 1 1
Separation Failure 1 1
Defective Device 1 1
Entrapment of Device 1 1
Off-Label Use 1 1
Device Appears to Trigger Rejection 1 1
Material Integrity Problem 1 1
Device Damaged by Another Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Positioning Problem 1 1
Activation Problem 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 643 643
Pain 183 183
No Code Available 172 172
Insufficient Information 77 77
Not Applicable 73 73
No Clinical Signs, Symptoms or Conditions 71 71
Unspecified Infection 68 68
Failure of Implant 61 61
Injury 52 52
Joint Dislocation 48 48
Metal Related Pathology 43 43
Bone Fracture(s) 27 27
Ambulation Difficulties 25 25
Foreign Body Reaction 23 23
Inadequate Osseointegration 21 21
Osteolysis 20 20
No Information 19 19
Loss of Range of Motion 18 18
Discomfort 17 17
Inflammation 14 14
No Known Impact Or Consequence To Patient 13 13
Tissue Damage 12 12
Ossification 12 12
Joint Laxity 12 12
Muscle/Tendon Damage 11 11
Swelling/ Edema 10 10
Scar Tissue 10 10
Test Result 10 10
Limited Mobility Of The Implanted Joint 10 10
Foreign Body In Patient 10 10
Hypersensitivity/Allergic reaction 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Hematoma 8 8
Adhesion(s) 8 8
Fall 8 8
Cyst(s) 7 7
Blood Loss 7 7
Reaction 7 7
Synovitis 7 7
Edema 6 6
Unspecified Tissue Injury 6 6
Unequal Limb Length 5 5
Thrombosis/Thrombus 5 5
Swelling 5 5
Hip Fracture 5 5
Arthralgia 4 4
Joint Disorder 4 4
Post Operative Wound Infection 4 4
Nerve Damage 4 4
Myocardial Infarction 4 4
Limb Fracture 4 4
Physical Asymmetry 4 4
Muscular Rigidity 3 3
Necrosis 3 3
Hemorrhage/Bleeding 3 3
Fever 3 3
Abscess 3 3
Bacterial Infection 3 3
Host-Tissue Reaction 2 2
High Blood Pressure/ Hypertension 2 2
Nausea 2 2
Skin Irritation 2 2
Chills 2 2
Weakness 2 2
Impaired Healing 2 2
Device Embedded In Tissue or Plaque 2 2
Implant Pain 2 2
Unspecified Musculoskeletal problem 2 2
Nodule 2 2
Subluxation 2 2
Malunion of Bone 1 1
Cancer 1 1
No Patient Involvement 1 1
Nervous System Injury 1 1
Burning Sensation 1 1
Toxicity 1 1
Distress 1 1
Sepsis 1 1
Thrombosis 1 1
Vomiting 1 1
Rash 1 1
Infiltration into Tissue 1 1
Hyperplasia 1 1
Headache 1 1
Ecchymosis 1 1
Fatigue 1 1
Erosion 1 1
Calcium Deposits/Calcification 1 1
Cellulitis 1 1
Chest Pain 1 1
Arthritis 1 1

-
-