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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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 224 224
Insufficient Information 107 107
Device Dislodged or Dislocated 54 54
Connection Problem 28 28
Biocompatibility 17 17
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 5 5
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 104 104
Joint Dislocation 93 93
No Clinical Signs, Symptoms or Conditions 63 63
Pain 55 55
Failure of Implant 47 47
Metal Related Pathology 28 28
No Known Impact Or Consequence To Patient 27 27
Insufficient Information 24 24
Osteolysis 19 19
No Consequences Or Impact To Patient 17 17
Inadequate Osseointegration 14 14
Bone Fracture(s) 13 13
Fall 11 11
Bacterial Infection 10 10
Joint Laxity 10 10
Hip Fracture 10 10
Arthralgia 9 9
Subluxation 7 7
Foreign Body Reaction 5 5
Inflammation 5 5
Deformity/ Disfigurement 5 5
Ambulation Difficulties 5 5
Discomfort 4 4
No Information 4 4
Swelling/ Edema 4 4
Infiltration into Tissue 4 4
Post Operative Wound Infection 4 4
Impaired Healing 4 4
Loss of Range of Motion 4 4
Implant Pain 4 4
Ischemic Heart Disease 3 3
Sepsis 3 3
Nerve Damage 3 3
Solid Tumour 2 2
Purulent Discharge 2 2
Unequal Limb Length 2 2
Synovitis 2 2
Wound Dehiscence 2 2
Fever 2 2
Local Reaction 2 2
Hematoma 2 2
Muscle/Tendon Damage 2 2
Scar Tissue 2 2
Failure to Anastomose 2 2
Thrombosis/Thrombus 2 2
Unspecified Tissue Injury 2 2
Muscular Rigidity 1 1
Pulmonary Dysfunction 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Osteomyelitis 1 1
Aspiration/Inhalation 1 1
Convulsion/Seizure 1 1
Laceration(s) 1 1
Tissue Breakdown 1 1
Ossification 1 1
Anemia 1 1
Hyperplasia 1 1
Fluid Discharge 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Low Blood Pressure/ Hypotension 1 1
Renal Failure 1 1
Hemorrhage/Bleeding 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
External Prosthetic Device Pain 1 1
Joint Disorder 1 1
Inadequate Pain Relief 1 1
Thromboembolism 1 1
Skin Inflammation/ Irritation 1 1
Apnea 1 1
Osteopenia/ Osteoporosis 1 1
Physical Asymmetry 1 1

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