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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
Regulation Description Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Product CodeMAY
Regulation Number 888.3353
Device Class 2

MDR Year MDR Reports MDR Events
2016 60 60
2017 33 33
2018 33 33
2019 11 11
2020 14 14
2021 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 42 42
Insufficient Information 36 36
Device Dislodged or Dislocated 23 23
Break 21 21
Adverse Event Without Identified Device or Use Problem 14 14
Appropriate Term/Code Not Available 8 8
Material Integrity Problem 6 6
Device Contaminated During Manufacture or Shipping 5 5
Naturally Worn 5 5
Material Fragmentation 4 4
Migration or Expulsion of Device 4 4
Detachment of Device or Device Component 4 4
Device Damaged Prior to Use 4 4
Tear, Rip or Hole in Device Packaging 4 4
Detachment Of Device Component 4 4
Metal Shedding Debris 3 3
Packaging Problem 2 2
Noise, Audible 2 2
Mechanical Problem 2 2
Difficult to Insert 2 2
Inadequacy of Device Shape and/or Size 2 2
Unstable 2 2
Device-Device Incompatibility 2 2
Material Deformation 2 2
Migration 1 1
Improper or Incorrect Procedure or Method 1 1
Unraveled Material 1 1
Loose or Intermittent Connection 1 1
Difficult or Delayed Positioning 1 1
Material Erosion 1 1
Difficult To Position 1 1
Device Slipped 1 1
Crack 1 1
Degraded 1 1
Disassembly 1 1
Material Too Soft/Flexible 1 1
Component Missing 1 1
Component or Accessory Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 31 31
Joint Dislocation 28 28
Pain 22 22
No Known Impact Or Consequence To Patient 21 21
Unspecified Infection 18 18
No Code Available 13 13
No Patient Involvement 13 13
No Consequences Or Impact To Patient 11 11
No Clinical Signs, Symptoms or Conditions 9 9
Fall 6 6
Failure of Implant 5 5
Swelling 4 4
Sepsis 3 3
Reaction 3 3
Blood Loss 2 2
Bone Fracture(s) 2 2
Scar Tissue 2 2
Osteolysis 2 2
Numbness 2 2
Hip Fracture 2 2
Ambulation Difficulties 2 2
Insufficient Information 1 1
Sleep Dysfunction 1 1
Hypovolemia 1 1
Toxicity 1 1
Memory Loss/Impairment 1 1
Loss of Range of Motion 1 1
Arthritis 1 1
Emotional Changes 1 1
Hearing Loss 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Tinnitus 1 1
Tissue Damage 1 1
Local Reaction 1 1
Headache 1 1
Necrosis 1 1
Limited Mobility Of The Implanted Joint 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 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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