Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 236 1736
Device Dislodged or Dislocated 26 27
Biocompatibility 25 27
Connection Problem 12 12
Loss of Osseointegration 10 10
Incomplete or Inadequate Connection 9 9
Osseointegration Problem 8 433
Loosening of Implant Not Related to Bone-Ingrowth 8 1505
Migration 8 8
Break 7 7
Failure to Align 7 7
Failure to Osseointegrate 7 7
Malposition of Device 6 1073
Material Erosion 6 1499
Fracture 6 434
Fitting Problem 5 5
Insufficient Information 5 5
Positioning Problem 5 5
Patient Device Interaction Problem 5 6
Degraded 5 5
Physical Resistance/Sticking 4 4
Positioning Failure 3 3
Naturally Worn 3 3
Improper or Incorrect Procedure or Method 2 430
Patient-Device Incompatibility 2 2
Unintended Movement 2 2
Defective Device 2 2
Difficult to Insert 2 2
Material Deformation 2 2
No Apparent Adverse Event 2 2
Mechanical Jam 1 1
Deformation Due to Compressive Stress 1 1
Loose or Intermittent Connection 1 1
Corroded 1 1
Premature Separation 1 1
Inaccurate Information 1 1
Nonstandard Device 1 1
Detachment of Device or Device Component 1 1
Inadequacy of Device Shape and/or Size 1 1
Delivered as Unsterile Product 1 1
Device Damaged by Another Device 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
Off-Label Use 1 1
Mechanical Problem 1 1
Compatibility Problem 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 73 1566
Joint Dislocation 71 1572
No Clinical Signs, Symptoms or Conditions 58 58
Failure of Implant 39 42
Insufficient Information 39 1534
Metal Related Pathology 34 464
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 7 7
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
Foreign Body In Patient 2 2
Fever 2 3
Purulent Discharge 2 2
Anemia 2 2
Failure to Anastomose 2 2
Hematoma 2 2
Unspecified Tissue Injury 2 2
Necrosis 2 430
Wound Dehiscence 2 2
Osteomyelitis 1 1
Muscular Rigidity 1 1
Nerve Damage 1 1
Jaundice 1 1
Cellulitis 1 1
Local Reaction 1 1
Laceration(s) 1 1
Scar Tissue 1 1

-
-