• 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 2

MDR Year MDR Reports MDR Events
2017 61 61
2018 111 111
2019 172 172
2020 115 115
2021 118 118
2022 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 166 166
Insufficient Information 161 161
Device Dislodged or Dislocated 76 76
Connection Problem 33 33
Loose or Intermittent Connection 27 27
Unintended Movement 21 21
Fitting Problem 20 20
Unstable 16 16
Break 12 12
Biocompatibility 12 12
Appropriate Term/Code Not Available 12 12
Incomplete or Inadequate Connection 10 10
Malposition of Device 6 6
Defective Device 5 5
Inadequacy of Device Shape and/or Size 5 5
Device Slipped 5 5
Fracture 5 5
Migration or Expulsion of Device 5 5
Mechanical Problem 4 4
Migration 4 4
Physical Resistance/Sticking 4 4
Positioning Problem 4 4
Osseointegration Problem 3 3
Patient Device Interaction Problem 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Device-Device Incompatibility 3 3
Compatibility Problem 3 3
No Apparent Adverse Event 3 3
Misconnection 3 3
Difficult to Insert 3 3
Failure to Align 3 3
Patient-Device Incompatibility 2 2
Loss of Osseointegration 2 2
High Test Results 2 2
Flaked 2 2
Degraded 2 2
Off-Label Use 2 2
Difficult to Remove 2 2
Naturally Worn 2 2
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Illegible Information 1 1
Inaccurate Information 1 1
Delivered as Unsterile Product 1 1
Misassembled 1 1
Difficult or Delayed Positioning 1 1
Positioning Failure 1 1
Detachment Of Device Component 1 1
Crack 1 1
Failure To Adhere Or Bond 1 1
Dull, Blunt 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Device Damaged by Another Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 188 188
Joint Dislocation 101 101
Unspecified Infection 99 99
Pain 62 63
No Clinical Signs, Symptoms or Conditions 57 57
Failure of Implant 52 52
No Known Impact Or Consequence To Patient 40 40
Metal Related Pathology 22 22
No Consequences Or Impact To Patient 17 17
No Code Available 13 13
Osteolysis 12 12
No Information 11 11
Insufficient Information 9 9
Fall 9 9
Bacterial Infection 8 8
Bone Fracture(s) 8 8
Subluxation 7 7
Joint Laxity 5 5
Limited Mobility Of The Implanted Joint 5 5
Hip Fracture 5 5
Arthralgia 4 4
Infiltration into Tissue 4 4
Ambulation Difficulties 4 4
Inadequate Osseointegration 4 4
Impaired Healing 4 4
Post Operative Wound Infection 4 4
Swelling/ Edema 4 4
Ischemic Heart Disease 3 3
Discomfort 3 3
Nerve Damage 3 3
Inflammation 3 3
Fever 3 3
Loss of Range of Motion 3 3
Sepsis 2 2
Swelling 2 2
Synovitis 2 2
Deformity/ Disfigurement 2 2
Foreign Body Reaction 2 2
Failure to Anastomose 2 2
Hematoma 2 2
Low Blood Pressure/ Hypotension 2 2
Test Result 2 2
Patch Test, Abnormal Results Of 2 2
Not Applicable 1 1
Device Embedded In Tissue or Plaque 1 1
Convulsion/Seizure 1 1
Thrombosis/Thrombus 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Muscle/Tendon Damage 1 1
Unequal Limb Length 1 1
Skin Inflammation/ Irritation 1 1
Solid Tumour 1 1
Implant Pain 1 1
Physical Asymmetry 1 1
Toxicity 1 1
Reaction, Injection Site 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Blood Loss 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Hyperplasia 1 1
Laceration(s) 1 1
Muscular Rigidity 1 1
Wound Dehiscence 1 1
Ossification 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Purulent Discharge 1 1
Joint Disorder 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Regurgitation 1 1
Pulmonary Dysfunction 1 1
Thyroid Problems 1 1
Vomiting 1 1
Local Reaction 1 1
Renal Failure 1 1
Scar Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Smith & Nephew, Inc. II Jun-09-2020
-
-