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, 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
Device Operates Differently Than Expected 11 11
Appropriate Term/Code Not Available 11 11
Material Deformation 10 10
Difficult to Remove 9 9
Fitting Problem 8 8
Noise, Audible 8 8
Loose or Intermittent Connection 8 8
Inadequacy of Device Shape and/or Size 7 7
Sticking 7 7
Metal Shedding Debris 7 7
Migration or Expulsion of Device 5 5
Tear, Rip or Hole in Device Packaging 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Fragmentation 5 5
Detachment of Device or Device Component 5 5
Crack 5 5
Device Damaged Prior to Use 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Mechanical Jam 4 4
Migration 4 4
Connection Problem 4 4
Component Missing 3 3
Device-Device Incompatibility 3 3
Failure to Disconnect 3 3
Difficult to Insert 3 3
Malposition of Device 3 3
Mechanics Altered 3 3
Component Falling 2 2
Material Erosion 2 2
Packaging Problem 2 2
Difficult To Position 2 2
Degraded 2 2
Use of Device Problem 2 2
Loss of or Failure to Bond 2 2
Disassembly 2 2
No Apparent Adverse Event 1 1
Difficult to Open or Close 1 1
Unraveled Material 1 1
Difficult or Delayed Positioning 1 1
Product Quality Problem 1 1
Device Contamination with Body Fluid 1 1
Improper or Incorrect Procedure or Method 1 1
Patient-Device Incompatibility 1 1
Nonstandard Device 1 1
Split 1 1
Material Too Soft/Flexible 1 1
Device Or Device Fragments Location Unknown 1 1
Positioning Problem 1 1
Disconnection 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Contamination with Chemical or Other Material 1 1
Contamination of Device Ingredient or Reagent 1 1
Physical Resistance/Sticking 1 1
Peeled/Delaminated 1 1
Component or Accessory Incompatibility 1 1
Material Separation 1 1
Material Protrusion/Extrusion 1 1
Separation Failure 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
Failure of Implant 15 15
No Patient Involvement 15 15
Bone Fracture(s) 13 13
Toxicity 11 11
Fall 9 9
Ambulation Difficulties 8 8
Injury 8 8
Insufficient Information 6 6
Osteolysis 5 5
Swelling 5 5
Scar Tissue 4 4
Test Result 3 3
Reaction 3 3
Complaint, Ill-Defined 3 3
Sepsis 3 3
Loss of Range of Motion 3 3
Tissue Damage 3 3
Swelling/ Edema 3 3
Osteopenia/ Osteoporosis 3 3
Numbness 2 2
Metal Related Pathology 2 2
Blood Loss 2 2
Device Embedded In Tissue or Plaque 2 2
Unequal Limb Length 2 2
Malunion of Bone 2 2
Foreign Body In Patient 2 2
Inflammation 2 2
Arthritis 2 2
Hip Fracture 2 2
Fibrosis 2 2
Tissue Breakdown 1 1
Ossification 1 1
Sleep Dysfunction 1 1
Emotional Changes 1 1
Headache 1 1
Discomfort 1 1
Synovitis 1 1
Purulent Discharge 1 1
Atrial Fibrillation 1 1
Memory Loss/Impairment 1 1
High Blood Pressure/ Hypertension 1 1
Local Reaction 1 1
Bacterial Infection 1 1
Limited Mobility Of The Implanted Joint 1 1
Joint Swelling 1 1
Disability 1 1
Necrosis 1 1
Tinnitus 1 1
Hearing Loss 1 1
Hematoma 1 1
Hypersensitivity/Allergic reaction 1 1
Fluid Discharge 1 1
Hypovolemia 1 1

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