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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
Regulation Description Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
Product CodeMBL
Regulation Number 888.3358
Device Class 2


Premarket Reviews
ManufacturerDecision
MICROPORT ORTHOPEDICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 54 54
2017 61 61
2018 111 111
2019 172 172
2020 115 115
2021 101 101

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 170 170
Adverse Event Without Identified Device or Use Problem 141 141
Device Dislodged or Dislocated 82 82
Connection Problem 35 35
Loose or Intermittent Connection 30 30
Unintended Movement 21 21
Fitting Problem 20 20
Unstable 18 18
Appropriate Term/Code Not Available 17 17
Incomplete or Inadequate Connection 10 10
Break 9 9
Fracture 6 6
Device Slipped 6 6
Malposition of Device 6 6
Defective Device 5 5
Difficult to Insert 5 5
Migration or Expulsion of Device 5 5
Inadequacy of Device Shape and/or Size 5 5
Positioning Problem 5 5
Physical Resistance/Sticking 4 4
Mechanical Problem 4 4
Failure to Align 4 4
Biocompatibility 4 4
Device Operates Differently Than Expected 4 4
Patient-Device Incompatibility 3 3
Misconnection 3 3
Migration 3 3
Patient Device Interaction Problem 3 3
Compatibility Problem 3 3
Osseointegration Problem 3 3
Device-Device Incompatibility 2 2
Naturally Worn 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
No Apparent Adverse Event 2 2
Difficult to Remove 2 2
Flaked 2 2
High Test Results 2 2
Use of Device Problem 1 1
Dull, Blunt 1 1
Loss of Osseointegration 1 1
Calibration Problem 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Failure To Adhere Or Bond 1 1
Detachment Of Device Component 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Delivered as Unsterile Product 1 1
Off-Label Use 1 1
Misassembled 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Illegible Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 188 188
Joint Dislocation 93 93
Unspecified Infection 91 91
Pain 56 57
No Clinical Signs, Symptoms or Conditions 50 50
No Known Impact Or Consequence To Patient 46 46
Failure of Implant 46 46
No Code Available 34 34
No Consequences Or Impact To Patient 19 19
No Information 15 15
Metal Related Pathology 14 14
Osteolysis 9 9
Insufficient Information 6 6
Bacterial Infection 6 6
Limited Mobility Of The Implanted Joint 5 5
Inadequate Osseointegration 4 4
Impaired Healing 4 4
Subluxation 4 4
Joint Laxity 4 4
Bone Fracture(s) 4 4
Inflammation 4 4
Fall 3 3
Hip Fracture 3 3
Swelling/ Edema 3 3
Post Operative Wound Infection 3 3
Ischemic Heart Disease 3 3
Discomfort 3 3
Nerve Damage 3 3
Foreign Body In Patient 3 3
Ambulation Difficulties 2 2
Test Result 2 2
Patch Test, Abnormal Results Of 2 2
Arthralgia 2 2
Loss of Range of Motion 2 2
Sepsis 2 2
Swelling 2 2
Fever 2 2
Foreign Body Reaction 2 2
Infiltration into Tissue 2 2
Low Blood Pressure/ Hypotension 2 2
Hematoma 1 1
Muscular Rigidity 1 1
Wound Dehiscence 1 1
Ossification 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Synovitis 1 1
Thyroid Problems 1 1
Vomiting 1 1
Local Reaction 1 1
Renal Failure 1 1
Scar Tissue 1 1
Deformity/ Disfigurement 1 1
Joint Disorder 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Regurgitation 1 1
Pulmonary Dysfunction 1 1
Not Applicable 1 1
Device Embedded In Tissue or Plaque 1 1
Muscle/Tendon Damage 1 1
Skin Inflammation/ Irritation 1 1
Solid Tumour 1 1
Implant Pain 1 1
Physical Asymmetry 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Blood Loss 1 1
Numbness 1 1
Reaction, Injection Site 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Toxicity 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1

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