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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 80 80
2024 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 260 260
Insufficient Information 108 108
Device Dislodged or Dislocated 55 55
Connection Problem 28 28
Biocompatibility 21 21
Fitting Problem 16 16
Loose or Intermittent Connection 15 15
Unstable 13 13
Unintended Movement 11 11
Incomplete or Inadequate Connection 10 10
Loss of Osseointegration 8 8
Break 8 8
Migration 8 8
Loosening of Implant Not Related to Bone-Ingrowth 8 8
Failure to Align 7 7
Failure to Osseointegrate 7 7
Positioning Problem 6 6
Defective Device 5 5
Fracture 5 5
Patient Device Interaction Problem 5 5
Inadequacy of Device Shape and/or Size 5 5
Osseointegration Problem 4 4
Malposition of Device 4 4
Physical Resistance/Sticking 4 4
Appropriate Term/Code Not Available 4 4
Degraded 4 4
Difficult to Insert 4 4
Compatibility Problem 3 3
Migration or Expulsion of Device 3 3
Naturally Worn 3 3
Positioning Failure 3 3
Flaked 2 2
Nonstandard Device 2 2
No Apparent Adverse Event 2 2
Misconnection 2 2
Patient-Device Incompatibility 2 2
Device-Device Incompatibility 2 2
Misassembled 1 1
Delivered as Unsterile Product 1 1
Calibration Problem 1 1
Device Damaged by Another Device 1 1
Use of Device Problem 1 1
Scratched Material 1 1
Illegible Information 1 1
Difficult to Remove 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Unsealed Device Packaging 1 1
Device Markings/Labelling Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 123 123
Unspecified Infection 112 112
Joint Dislocation 97 97
No Clinical Signs, Symptoms or Conditions 64 64
Pain 56 56
Failure of Implant 49 49
Metal Related Pathology 32 32
Insufficient Information 28 28
No Known Impact Or Consequence To Patient 27 27
Osteolysis 19 19
Inadequate Osseointegration 18 18
No Consequences Or Impact To Patient 17 17
Bone Fracture(s) 17 17
Joint Laxity 13 13
Hip Fracture 11 11
Fall 11 11
Bacterial Infection 10 10
Arthralgia 10 10
Swelling/ Edema 7 7
Subluxation 7 7
Implant Pain 6 6
Ambulation Difficulties 5 5
Deformity/ Disfigurement 5 5
Inflammation 5 5
Foreign Body Reaction 5 5
Impaired Healing 4 4
Infiltration into Tissue 4 4
No Information 4 4
Muscle/Tendon Damage 4 4
Loss of Range of Motion 4 4
Post Operative Wound Infection 4 4
Discomfort 4 4
Sepsis 3 3
Ischemic Heart Disease 3 3
Nerve Damage 3 3
Thrombosis/Thrombus 3 3
Unspecified Tissue Injury 2 2
Failure to Anastomose 2 2
Scar Tissue 2 2
Unequal Limb Length 2 2
Fever 2 2
Anemia 2 2
Purulent Discharge 2 2
Local Reaction 2 2
Hematoma 2 2
Synovitis 2 2
Solid Tumour 2 2
Wound Dehiscence 2 2
Osteomyelitis 1 1
Burning Sensation 1 1

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