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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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 83 83
Insufficient Information 70 70
Break 69 69
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
Noise, Audible 8 8
Loose or Intermittent Connection 8 8
Fitting Problem 8 8
Metal Shedding Debris 7 7
Inadequacy of Device Shape and/or Size 7 7
Sticking 7 7
Detachment of Device or Device Component 5 5
Tear, Rip or Hole in Device Packaging 5 5
Material Fragmentation 5 5
Device Contaminated During Manufacture or Shipping 5 5
Migration or Expulsion of Device 5 5
Crack 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Mechanical Jam 4 4
Connection Problem 4 4
Device Damaged Prior to Use 4 4
Migration 4 4
Failure to Disconnect 3 3
Difficult to Insert 3 3
Component Missing 3 3
Mechanics Altered 3 3
Device-Device Incompatibility 3 3
Malposition of Device 3 3
Loss of or Failure to Bond 2 2
Component Falling 2 2
Difficult To Position 2 2
Material Erosion 2 2
Packaging Problem 2 2
Use of Device Problem 2 2
Degraded 2 2
Disassembly 2 2
Device Disinfection Or Sterilization Issue 1 1
Peeled/Delaminated 1 1
Split 1 1
Device Contamination with Chemical or Other Material 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 21 21
No Patient Involvement 15 15
Failure of Implant 15 15
Bone Fracture(s) 13 13
Toxicity 11 11
Fall 9 9
Ambulation Difficulties 8 8
Injury 8 8
Insufficient Information 7 7
Osteolysis 5 5
Swelling 5 5
Scar Tissue 4 4
Complaint, Ill-Defined 3 3
Sepsis 3 3
Reaction 3 3
Test Result 3 3
Loss of Range of Motion 3 3
Tissue Damage 3 3
Swelling/ Edema 3 3
Osteopenia/ Osteoporosis 3 3
Unequal Limb Length 2 2
Numbness 2 2
Foreign Body In Patient 2 2
Blood Loss 2 2
Malunion of Bone 2 2
Inflammation 2 2
Metal Related Pathology 2 2
Fibrosis 2 2
Arthritis 2 2
Hip Fracture 2 2
Device Embedded In Tissue or Plaque 2 2
Fluid Discharge 1 1
Bacterial Infection 1 1
Headache 1 1
Tinnitus 1 1
Tissue Breakdown 1 1
Hypovolemia 1 1
Joint Swelling 1 1
Discomfort 1 1
Ossification 1 1
Local Reaction 1 1
Purulent Discharge 1 1
Atrial Fibrillation 1 1

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