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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
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 242 242
Insufficient Information 148 148
Device Dislodged or Dislocated 73 73
Connection Problem 30 30
Loose or Intermittent Connection 23 23
Fitting Problem 19 19
Biocompatibility 17 17
Unstable 15 15
Unintended Movement 15 15
Break 11 11
Incomplete or Inadequate Connection 10 10
Appropriate Term/Code Not Available 9 9
Migration 8 8
Positioning Problem 7 7
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Loss of Osseointegration 7 7
Failure to Align 7 7
Fracture 6 6
Inadequacy of Device Shape and/or Size 5 5
Degraded 5 5
Defective Device 5 5
Malposition of Device 5 5
Failure to Osseointegrate 5 5
Mechanical Problem 4 4
Difficult to Insert 4 4
Physical Resistance/Sticking 4 4
Patient Device Interaction Problem 4 4
Osseointegration Problem 4 4
Naturally Worn 3 3
Compatibility Problem 3 3
No Apparent Adverse Event 3 3
Migration or Expulsion of Device 3 3
Positioning Failure 3 3
Flaked 2 2
Misconnection 2 2
Nonstandard Device 2 2
High Test Results 2 2
Patient-Device Incompatibility 2 2
Device-Device Incompatibility 2 2
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
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
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Device Slipped 1 1
Crack 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 169 169
Unspecified Infection 117 117
Joint Dislocation 117 117
Pain 66 67
No Clinical Signs, Symptoms or Conditions 63 63
Failure of Implant 54 54
No Known Impact Or Consequence To Patient 35 35
Metal Related Pathology 28 28
Insufficient Information 24 24
Osteolysis 20 20
No Consequences Or Impact To Patient 17 17
Inadequate Osseointegration 15 15
Bone Fracture(s) 13 13
Hip Fracture 12 12
Fall 11 11
Bacterial Infection 10 10
Joint Laxity 10 10
No Information 9 9
Arthralgia 9 9
Subluxation 7 7
Ambulation Difficulties 6 6
Post Operative Wound Infection 6 6
Discomfort 5 5
Limited Mobility Of The Implanted Joint 5 5
Deformity/ Disfigurement 5 5
Inflammation 5 5
Foreign Body Reaction 5 5
Infiltration into Tissue 4 4
Loss of Range of Motion 4 4
Impaired Healing 4 4
Implant Pain 4 4
Swelling/ Edema 4 4
Ischemic Heart Disease 3 3
Nerve Damage 3 3
Sepsis 3 3
Fever 3 3
Purulent Discharge 2 2
Failure to Anastomose 2 2
Wound Dehiscence 2 2
Hematoma 2 2
Synovitis 2 2
Scar Tissue 2 2
Local Reaction 2 2
Solid Tumour 2 2
Unspecified Tissue Injury 2 2
Muscle/Tendon Damage 2 2
Unequal Limb Length 2 2
Patch Test, Abnormal Results Of 2 2
Thrombosis/Thrombus 2 2
No Code Available 2 2
Test Result 2 2
Device Embedded In Tissue or Plaque 1 1
Convulsion/Seizure 1 1
Skin Inflammation/ Irritation 1 1
Osteomyelitis 1 1
External Prosthetic Device Pain 1 1
Physical Asymmetry 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Inadequate Pain Relief 1 1
Reaction, Injection Site 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Renal Failure 1 1
Laceration(s) 1 1
Muscular Rigidity 1 1
Pulmonary Dysfunction 1 1
Thyroid Problems 1 1
Swelling 1 1
Joint Disorder 1 1
Hemorrhage/Bleeding 1 1
Hyperplasia 1 1
Low Blood Pressure/ Hypotension 1 1
Ossification 1 1
Anemia 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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