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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
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
2018 111 111
2019 172 172
2020 115 115
2021 118 118
2022 92 92
2023 49 49

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 227 227
Insufficient Information 148 148
Device Dislodged or Dislocated 71 71
Connection Problem 30 30
Loose or Intermittent Connection 23 23
Fitting Problem 19 19
Unstable 15 15
Unintended Movement 15 15
Biocompatibility 14 14
Break 11 11
Incomplete or Inadequate Connection 10 10
Appropriate Term/Code Not Available 9 9
Failure to Align 7 7
Defective Device 5 5
Malposition of Device 5 5
Loss of Osseointegration 5 5
Fracture 5 5
Inadequacy of Device Shape and/or Size 5 5
Migration 5 5
Physical Resistance/Sticking 4 4
Patient Device Interaction Problem 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Osseointegration Problem 4 4
Positioning Problem 4 4
Difficult to Insert 4 4
Degraded 4 4
Mechanical Problem 4 4
Failure to Osseointegrate 4 4
Migration or Expulsion of Device 3 3
Compatibility Problem 3 3
No Apparent Adverse Event 3 3
Device-Device Incompatibility 2 2
Naturally Worn 2 2
Positioning Failure 2 2
Flaked 2 2
Misconnection 2 2
High Test Results 2 2
Patient-Device Incompatibility 2 2
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Dull, Blunt 1 1
Improper or Incorrect Procedure or Method 1 1
Use of Device Problem 1 1
Delivered as Unsterile Product 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Device Slipped 1 1
Crack 1 1
Misassembled 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
Premature Separation 1 1
Illegible Information 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 169 169
Unspecified Infection 113 113
Joint Dislocation 112 112
Pain 63 64
No Clinical Signs, Symptoms or Conditions 59 59
Failure of Implant 47 47
No Known Impact Or Consequence To Patient 35 35
Metal Related Pathology 23 23
Insufficient Information 21 21
Osteolysis 17 17
No Consequences Or Impact To Patient 17 17
Hip Fracture 12 12
Inadequate Osseointegration 12 12
Bone Fracture(s) 10 10
Bacterial Infection 10 10
Fall 9 9
No Information 9 9
Joint Laxity 8 8
Arthralgia 8 8
Subluxation 7 7
Ambulation Difficulties 5 5
Deformity/ Disfigurement 5 5
Post Operative Wound Infection 5 5
Limited Mobility Of The Implanted Joint 5 5
Infiltration into Tissue 5 5
Inflammation 5 5
Foreign Body Reaction 5 5
Impaired Healing 4 4
Swelling/ Edema 4 4
Ischemic Heart Disease 3 3
Loss of Range of Motion 3 3
Nerve Damage 3 3
Discomfort 3 3
Fever 3 3
Purulent Discharge 2 2
Failure to Anastomose 2 2
Hematoma 2 2
Sepsis 2 2
Synovitis 2 2
Local Reaction 2 2
Test Result 2 2
Patch Test, Abnormal Results Of 2 2
No Code Available 2 2
Unspecified Tissue Injury 2 2
Implant Pain 2 2
Unequal Limb Length 2 2
Skin Inflammation/ Irritation 1 1
Solid Tumour 1 1
Muscle/Tendon Damage 1 1
Osteomyelitis 1 1
Physical Asymmetry 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Convulsion/Seizure 1 1
Thrombosis/Thrombus 1 1
Device Embedded In Tissue or Plaque 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Reaction, Injection Site 1 1
Joint Disorder 1 1
Renal Failure 1 1
Scar Tissue 1 1
Pulmonary Dysfunction 1 1
Thyroid Problems 1 1
Swelling 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Hyperplasia 1 1
Low Blood Pressure/ Hypotension 1 1
Laceration(s) 1 1
Muscular Rigidity 1 1
Wound Dehiscence 1 1
Ossification 1 1
Apnea 1 1
Aspiration/Inhalation 1 1

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