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, uncemented, metal/polymer, porous
Product CodeMBL
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 15 15
2015 55 55
2016 54 54
2017 61 61
2018 112 112
2019 172 172
2020 115 115
2021 116 116
2022 90 90
2023 79 79
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 267 267
Insufficient Information 178 178
Device Dislodged or Dislocated 121 121
Connection Problem 37 37
Loose or Intermittent Connection 36 36
Appropriate Term/Code Not Available 23 23
Unintended Movement 21 21
Fitting Problem 21 21
Unstable 18 18
Biocompatibility 17 17
Break 15 15
Fracture 10 10
Device Slipped 10 10
Positioning Problem 10 10
Incomplete or Inadequate Connection 10 10
Migration 8 8
Failure to Align 8 8
Malposition of Device 8 8
Difficult to Insert 8 8
Migration or Expulsion of Device 8 8
Loss of Osseointegration 7 7
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Device Operates Differently Than Expected 6 6
Inadequacy of Device Shape and/or Size 6 6
Failure to Osseointegrate 5 5
Degraded 5 5
Defective Device 5 5
Naturally Worn 5 5
Osseointegration Problem 5 5
Patient Device Interaction Problem 4 4
Physical Resistance/Sticking 4 4
Mechanical Problem 4 4
Positioning Failure 3 3
Difficult to Remove 3 3
Misconnection 3 3
Nonstandard Device 3 3
No Apparent Adverse Event 3 3
Patient-Device Incompatibility 3 3
Device-Device Incompatibility 3 3
Compatibility Problem 3 3
Off-Label Use 2 2
Improper or Incorrect Procedure or Method 2 2
High Test Results 2 2
Flaked 2 2
Failure To Adhere Or Bond 1 1
Leak/Splash 1 1
Misassembled 1 1
Disconnection 1 1
Difficult or Delayed Positioning 1 1
Detachment Of Device Component 1 1
Corroded 1 1
Crack 1 1
Dull, Blunt 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Material Separation 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Premature Separation 1 1
Illegible Information 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 190 190
Unspecified Infection 141 141
Joint Dislocation 138 138
Pain 84 85
Failure of Implant 73 73
No Code Available 67 67
No Clinical Signs, Symptoms or Conditions 63 63
No Known Impact Or Consequence To Patient 53 53
Metal Related Pathology 28 28
Insufficient Information 24 24
Osteolysis 21 21
No Information 20 20
No Consequences Or Impact To Patient 20 20
Bone Fracture(s) 16 16
Fall 15 15
Inadequate Osseointegration 15 15
Hip Fracture 13 13
Bacterial Infection 11 11
Joint Laxity 10 10
Arthralgia 9 9
Inflammation 8 8
Ambulation Difficulties 7 7
Subluxation 7 7
Post Operative Wound Infection 6 6
Toxicity 6 6
Loss of Range of Motion 6 6
Foreign Body Reaction 5 5
Discomfort 5 5
Deformity/ Disfigurement 5 5
Foreign Body In Patient 5 5
Limited Mobility Of The Implanted Joint 5 5
Impaired Healing 4 4
Infiltration into Tissue 4 4
Sepsis 4 4
Swelling/ Edema 4 4
Implant Pain 4 4
Nerve Damage 3 3
Purulent Discharge 3 3
Fever 3 3
Ischemic Heart Disease 3 3
Complaint, Ill-Defined 2 2
Scar Tissue 2 2
Test Result 2 2
Device Embedded In Tissue or Plaque 2 2
Patch Test, Abnormal Results Of 2 2
Thrombosis/Thrombus 2 2
Muscle/Tendon Damage 2 2
Failure to Anastomose 2 2
Wound Dehiscence 2 2
Low Blood Pressure/ Hypotension 2 2
Hematoma 2 2
Local Reaction 2 2
Swelling 2 2
Synovitis 2 2
Unequal Limb Length 2 2
Solid Tumour 2 2
Unspecified Tissue Injury 2 2
External Prosthetic Device Pain 1 1
Skin Inflammation/ Irritation 1 1
Physical Asymmetry 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Thyroid Problems 1 1
Tissue Damage 1 1
Vomiting 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Regurgitation 1 1
Pulmonary Dysfunction 1 1
Renal Failure 1 1
Staphylococcus Aureus 1 1
Laceration(s) 1 1
Muscular Rigidity 1 1
Hemorrhage/Bleeding 1 1
Hyperplasia 1 1
Ossification 1 1
Anemia 1 1
Apnea 1 1
Arthritis 1 1
Aspiration/Inhalation 1 1
Osteomyelitis 1 1
Convulsion/Seizure 1 1
Fibrosis 1 1
Not Applicable 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Joint Disorder 1 1
Blood Loss 1 1
Inadequate Pain Relief 1 1
Numbness 1 1
Reaction, Injection Site 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MicroPort Orthopedics, Inc. I Sep-28-2015
2 Ortho Development Corporation II Jun-20-2011
3 Smith & Nephew Inc II Feb-21-2014
4 Smith & Nephew Inc II Aug-08-2013
5 Smith & Nephew, Inc. II Jun-09-2020
-
-