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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

MDR Year MDR Reports MDR Events
2021 116 117
2022 90 99
2023 78 79
2024 54 54
2025 43 1535
2026 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 233 1733
Device Dislodged or Dislocated 26 27
Biocompatibility 24 26
Connection Problem 12 12
Loss of Osseointegration 10 10
Incomplete or Inadequate Connection 9 9
Loosening of Implant Not Related to Bone-Ingrowth 8 1505
Migration 8 8
Osseointegration Problem 8 433
Failure to Align 7 7
Failure to Osseointegrate 7 7
Material Erosion 6 1499
Fracture 6 434
Malposition of Device 6 1073
Positioning Problem 5 5
Break 5 5
Degraded 5 5
Insufficient Information 5 5
Patient Device Interaction Problem 5 6
Fitting Problem 5 5
Naturally Worn 3 3
Physical Resistance/Sticking 3 3
Positioning Failure 3 3
Improper or Incorrect Procedure or Method 2 430
Defective Device 2 2
Difficult to Insert 2 2
Material Deformation 2 2
Patient-Device Incompatibility 2 2
Unintended Movement 2 2
No Apparent Adverse Event 2 2
Premature Separation 1 1
Inaccurate Information 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1
Mechanical Jam 1 1
Compatibility Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Inadequacy of Device Shape and/or Size 1 1
Corroded 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 73 1566
Joint Dislocation 70 1571
No Clinical Signs, Symptoms or Conditions 57 57
Failure of Implant 39 42
Insufficient Information 39 1534
Metal Related Pathology 33 463
Pain 33 462
Bone Fracture(s) 22 1087
Osteolysis 18 450
Joint Laxity 16 442
Inadequate Osseointegration 15 16
Fall 11 11
Deformity/ Disfigurement 10 1506
Hip Fracture 10 11
Arthralgia 10 10
Bacterial Infection 9 9
Swelling/ Edema 7 7
Implant Pain 6 6
Ambulation Difficulties 5 6
Solid Tumour 4 432
Muscle/Tendon Damage 4 4
Inflammation 4 4
Subluxation 4 4
Foreign Body Reaction 4 4
Loss of Range of Motion 4 5
Infiltration into Tissue 3 3
Unequal Limb Length 3 431
Discomfort 3 3
Thrombosis/Thrombus 3 3
Post Operative Wound Infection 3 3
Ossification 3 431
Synovitis 3 431
Sepsis 3 3
Fever 2 3
Purulent Discharge 2 2
Anemia 2 2
Failure to Anastomose 2 2
Hematoma 2 2
Unspecified Tissue Injury 2 2
Wound Dehiscence 2 2
Foreign Body In Patient 1 1
Osteomyelitis 1 1
Muscular Rigidity 1 1
Nerve Damage 1 1
Cellulitis 1 1
Local Reaction 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Fluid Discharge 1 1
Perforation 1 1

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