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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 1

MDR Year MDR Reports MDR Events
2019 172 172
2020 115 115
2021 116 116
2022 90 90
2023 79 79
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 228 228
Insufficient Information 107 107
Device Dislodged or Dislocated 54 54
Connection Problem 28 28
Biocompatibility 19 19
Fitting Problem 16 16
Loose or Intermittent Connection 15 15
Unstable 13 13
Incomplete or Inadequate Connection 10 10
Unintended Movement 10 10
Migration 8 8
Break 8 8
Failure to Align 7 7
Loosening of Implant Not Related to Bone-Ingrowth 7 7
Positioning Problem 6 6
Loss of Osseointegration 6 6
Defective Device 5 5
Failure to Osseointegrate 5 5
Inadequacy of Device Shape and/or Size 5 5
Degraded 4 4
Fracture 4 4
Difficult to Insert 4 4
Malposition of Device 4 4
Osseointegration Problem 4 4
Appropriate Term/Code Not Available 4 4
Patient Device Interaction Problem 4 4
Physical Resistance/Sticking 4 4
Naturally Worn 3 3
Compatibility Problem 3 3
Migration or Expulsion of Device 3 3
Positioning Failure 3 3
Flaked 2 2
Misconnection 2 2
Nonstandard Device 2 2
Patient-Device Incompatibility 2 2
Device-Device Incompatibility 2 2
No Apparent Adverse Event 2 2
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Premature Separation 1 1
Illegible Information 1 1
Inaccurate Information 1 1
Improper or Incorrect Procedure or Method 1 1
Dull, Blunt 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1
Mechanical Jam 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
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
Use of Device Problem 1 1
Crack 1 1
Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 123 123
Unspecified Infection 105 105
Joint Dislocation 93 93
No Clinical Signs, Symptoms or Conditions 63 63
Pain 56 56
Failure of Implant 48 48
Metal Related Pathology 30 30
No Known Impact Or Consequence To Patient 27 27
Insufficient Information 25 25
Osteolysis 19 19
No Consequences Or Impact To Patient 17 17
Inadequate Osseointegration 15 15
Bone Fracture(s) 13 13
Fall 11 11
Bacterial Infection 10 10
Hip Fracture 10 10
Joint Laxity 10 10
Arthralgia 9 9
Subluxation 7 7
Ambulation Difficulties 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
No Information 4 4
Impaired Healing 4 4
Discomfort 4 4
Post Operative Wound Infection 4 4
Implant Pain 4 4
Swelling/ Edema 4 4
Muscle/Tendon Damage 3 3
Ischemic Heart Disease 3 3
Nerve Damage 3 3
Sepsis 3 3
Scar Tissue 2 2
Local Reaction 2 2
Hematoma 2 2
Purulent Discharge 2 2
Fever 2 2
Failure to Anastomose 2 2
Wound Dehiscence 2 2
Synovitis 2 2
Thrombosis/Thrombus 2 2
Unequal Limb Length 2 2
Solid Tumour 2 2
Unspecified Tissue Injury 2 2
External Prosthetic Device Pain 1 1
Skin Inflammation/ Irritation 1 1
Osteomyelitis 1 1
Physical Asymmetry 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Convulsion/Seizure 1 1
Osteopenia/ Osteoporosis 1 1
Thromboembolism 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Inadequate Pain Relief 1 1
Ossification 1 1
Anemia 1 1
Apnea 1 1
Aspiration/Inhalation 1 1
Hemorrhage/Bleeding 1 1
Hyperplasia 1 1
Low Blood Pressure/ Hypotension 1 1
Renal Failure 1 1
Laceration(s) 1 1
Muscular Rigidity 1 1
Pulmonary Dysfunction 1 1
Swelling 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Joint Disorder 1 1

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