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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
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 115 115
2021 116 116
2022 90 90
2023 80 80
2024 54 54
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 255 255
Device Dislodged or Dislocated 30 30
Biocompatibility 21 21
Insufficient Information 21 21
Connection Problem 18 18
Fitting Problem 12 12
Incomplete or Inadequate Connection 10 10
Unintended Movement 10 10
Loosening of Implant Not Related to Bone-Ingrowth 9 9
Loss of Osseointegration 8 8
Migration 8 8
Break 7 7
Failure to Align 7 7
Failure to Osseointegrate 7 7
Positioning Problem 6 6
Loose or Intermittent Connection 5 5
Defective Device 5 5
Patient Device Interaction Problem 5 5
Osseointegration Problem 4 4
Malposition of Device 4 4
Degraded 4 4
Difficult to Insert 4 4
Inadequacy of Device Shape and/or Size 4 4
Compatibility Problem 3 3
Physical Resistance/Sticking 3 3
Naturally Worn 3 3
Positioning Failure 3 3
Nonstandard Device 2 2
Appropriate Term/Code Not Available 2 2
Fracture 2 2
No Apparent Adverse Event 2 2
Patient-Device Incompatibility 2 2
Device-Device Incompatibility 2 2
Unstable 2 2
Misconnection 1 1
Delivered as Unsterile Product 1 1
Device Damaged by Another Device 1 1
Use of Device Problem 1 1
Scratched Material 1 1
Difficult to Remove 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unsealed Device Packaging 1 1
Device Markings/Labelling Problem 1 1
Crack 1 1
Inaccurate Information 1 1
Premature Separation 1 1
Off-Label Use 1 1
Improper or Incorrect Procedure or Method 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 91 91
Joint Dislocation 68 68
No Clinical Signs, Symptoms or Conditions 63 63
Failure of Implant 50 50
Injury 41 41
Pain 35 35
Metal Related Pathology 32 32
Insufficient Information 28 28
No Known Impact Or Consequence To Patient 21 21
Osteolysis 20 20
Inadequate Osseointegration 18 18
Bone Fracture(s) 18 18
Joint Laxity 13 13
Hip Fracture 11 11
Arthralgia 11 11
Fall 11 11
Bacterial Infection 10 10
Subluxation 7 7
Swelling/ Edema 7 7
Implant Pain 6 6
Ambulation Difficulties 5 5
Inflammation 5 5
Foreign Body Reaction 5 5
Deformity/ Disfigurement 5 5
Muscle/Tendon Damage 4 4
Loss of Range of Motion 4 4
Post Operative Wound Infection 4 4
Infiltration into Tissue 4 4
No Information 4 4
Impaired Healing 4 4
Ischemic Heart Disease 3 3
Thrombosis/Thrombus 3 3
Nerve Damage 3 3
Discomfort 3 3
Sepsis 3 3
No Consequences Or Impact To Patient 2 2
Purulent Discharge 2 2
Anemia 2 2
Fever 2 2
Synovitis 2 2
Hematoma 2 2
Unequal Limb Length 2 2
Unspecified Tissue Injury 2 2
Solid Tumour 2 2
Scar Tissue 2 2
Failure to Anastomose 2 2
Wound Dehiscence 2 2
Hemorrhage/Bleeding 1 1
Inadequate Pain Relief 1 1
Physical Asymmetry 1 1

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