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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, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
Product CodeMAY
Regulation Number 888.3353
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 94 94
2015 115 115
2016 60 60
2017 33 33
2018 33 33
2019 11 11
2020 14 14
2021 24 24
2022 11 11
2023 8 8
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 81 81
Insufficient Information 70 70
Break 67 67
Device Dislodged or Dislocated 47 47
Adverse Event Without Identified Device or Use Problem 40 40
Material Integrity Problem 22 22
Detachment Of Device Component 15 15
Device Slipped 14 14
Naturally Worn 13 13
Mechanical Problem 12 12
Unstable 11 11
Appropriate Term/Code Not Available 11 11
Device Operates Differently Than Expected 11 11
Material Deformation 10 10
Difficult to Remove 9 9
Loose or Intermittent Connection 8 8
Fitting Problem 8 8
Noise, Audible 8 8
Metal Shedding Debris 7 7
Inadequacy of Device Shape and/or Size 7 7
Sticking 7 7
Tear, Rip or Hole in Device Packaging 5 5
Migration or Expulsion of Device 5 5
Material Fragmentation 5 5
Crack 5 5
Device Contaminated During Manufacture or Shipping 5 5
Detachment of Device or Device Component 5 5
Connection Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Migration 4 4
Mechanical Jam 4 4
Device Damaged Prior to Use 4 4
Component Missing 3 3
Difficult to Insert 3 3
Mechanics Altered 3 3
Device-Device Incompatibility 3 3
Failure to Disconnect 3 3
Malposition of Device 3 3
Packaging Problem 2 2
Difficult To Position 2 2
Degraded 2 2
Component Falling 2 2
Disassembly 2 2
Loss of or Failure to Bond 2 2
Material Erosion 2 2
Use of Device Problem 2 2
Unraveled Material 1 1
Material Separation 1 1
Device Contamination with Body Fluid 1 1
Split 1 1
Improper or Incorrect Procedure or Method 1 1
Disconnection 1 1
Difficult or Delayed Positioning 1 1
Product Quality Problem 1 1
Nonstandard Device 1 1
Peeled/Delaminated 1 1
Positioning Problem 1 1
No Apparent Adverse Event 1 1
Material Too Soft/Flexible 1 1
Physical Resistance/Sticking 1 1
Patient-Device Incompatibility 1 1
Component or Accessory Incompatibility 1 1
Separation Failure 1 1
Device Or Device Fragments Location Unknown 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Disinfection Or Sterilization Issue 1 1
Difficult to Open or Close 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 129 129
Pain 51 51
No Code Available 44 44
No Information 42 42
Joint Dislocation 41 41
Unspecified Infection 36 36
No Consequences Or Impact To Patient 33 33
No Clinical Signs, Symptoms or Conditions 20 20
No Patient Involvement 15 15
Failure of Implant 15 15
Bone Fracture(s) 13 13
Toxicity 11 11
Fall 9 9
Injury 8 8
Ambulation Difficulties 8 8
Insufficient Information 6 6
Osteolysis 5 5
Swelling 5 5
Scar Tissue 4 4
Sepsis 3 3
Tissue Damage 3 3
Reaction 3 3
Loss of Range of Motion 3 3
Swelling/ Edema 3 3
Complaint, Ill-Defined 3 3
Osteopenia/ Osteoporosis 3 3
Test Result 3 3
Device Embedded In Tissue or Plaque 2 2
Fibrosis 2 2
Malunion of Bone 2 2
Metal Related Pathology 2 2
Unequal Limb Length 2 2
Foreign Body In Patient 2 2
Blood Loss 2 2
Inflammation 2 2
Arthritis 2 2
Numbness 2 2
Hip Fracture 2 2
Joint Swelling 1 1
Disability 1 1
Sleep Dysfunction 1 1
Hypovolemia 1 1
Discomfort 1 1
Synovitis 1 1
Tinnitus 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Purulent Discharge 1 1
Emotional Changes 1 1
Headache 1 1
Hearing Loss 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Memory Loss/Impairment 1 1
Necrosis 1 1
Local Reaction 1 1
Ossification 1 1
Limited Mobility Of The Implanted Joint 1 1
Tissue Breakdown 1 1
Fluid Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Howmedica Osteonics Corp. II Feb-25-2016
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