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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 2

MDR Year MDR Reports MDR Events
2017 61 61
2018 111 111
2019 172 172
2020 115 115
2021 117 117

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 161 161
Adverse Event Without Identified Device or Use Problem 148 148
Device Dislodged or Dislocated 68 68
Connection Problem 33 33
Loose or Intermittent Connection 27 27
Unintended Movement 21 21
Fitting Problem 20 20
Unstable 16 16
Appropriate Term/Code Not Available 12 12
Incomplete or Inadequate Connection 10 10
Break 9 9
Fracture 5 5
Migration or Expulsion of Device 5 5
Device Slipped 5 5
Defective Device 5 5
Malposition of Device 5 5
Biocompatibility 4 4
Inadequacy of Device Shape and/or Size 4 4
Mechanical Problem 4 4
Physical Resistance/Sticking 4 4
Migration 3 3
Patient Device Interaction Problem 3 3
Device-Device Incompatibility 3 3
Compatibility Problem 3 3
Osseointegration Problem 3 3
Positioning Problem 3 3
Misconnection 3 3
Difficult to Insert 3 3
Failure to Align 3 3
High Test Results 2 2
Patient-Device Incompatibility 2 2
Flaked 2 2
Naturally Worn 2 2
No Apparent Adverse Event 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
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
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
Difficult to Remove 1 1
Misassembled 1 1
Calibration 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
Dull, Blunt 1 1
Loss of Osseointegration 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 188 188
Joint Dislocation 92 92
Unspecified Infection 89 89
Pain 54 55
No Clinical Signs, Symptoms or Conditions 52 52
Failure of Implant 48 48
No Known Impact Or Consequence To Patient 40 40
No Consequences Or Impact To Patient 17 17
Metal Related Pathology 14 14
No Code Available 13 13
No Information 11 11
Osteolysis 10 10
Bacterial Infection 7 7
Insufficient Information 6 6
Subluxation 5 5
Limited Mobility Of The Implanted Joint 5 5
Bone Fracture(s) 5 5
Inadequate Osseointegration 4 4
Impaired Healing 4 4
Joint Laxity 4 4
Swelling/ Edema 3 3
Post Operative Wound Infection 3 3
Ischemic Heart Disease 3 3
Ambulation Difficulties 3 3
Discomfort 3 3
Nerve Damage 3 3
Inflammation 3 3
Hip Fracture 3 3
Arthralgia 2 2
Loss of Range of Motion 2 2
Sepsis 2 2
Swelling 2 2
Hematoma 2 2
Low Blood Pressure/ Hypotension 2 2
Infiltration into Tissue 2 2
Fall 2 2
Fever 2 2
Foreign Body Reaction 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
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
Toxicity 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Blood Loss 1 1
Reaction, Injection Site 1 1
Purulent Discharge 1 1
Wound Dehiscence 1 1
Ossification 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Muscular Rigidity 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

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