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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 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 43 43
Insufficient Information 36 36
Device Dislodged or Dislocated 23 23
Break 21 21
Adverse Event Without Identified Device or Use Problem 17 17
Appropriate Term/Code Not Available 8 8
Material Integrity Problem 6 6
Naturally Worn 5 5
Device Contaminated During Manufacture or Shipping 5 5
Detachment Of Device Component 4 4
Material Fragmentation 4 4
Detachment of Device or Device Component 4 4
Device Damaged Prior to Use 4 4
Migration 4 4
Unstable 4 4
Tear, Rip or Hole in Device Packaging 4 4
Migration or Expulsion of Device 4 4
Metal Shedding Debris 3 3
Difficult to Insert 3 3
Packaging Problem 2 2
Noise, Audible 2 2
Mechanical Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Device-Device Incompatibility 2 2
Material Deformation 2 2
Physical Resistance/Sticking 1 1
Component or Accessory Incompatibility 1 1
Difficult To Position 1 1
Device Slipped 1 1
Crack 1 1
Material Too Soft/Flexible 1 1
Loose or Intermittent Connection 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Erosion 1 1
Component Missing 1 1
Loss of or Failure to Bond 1 1
Degraded 1 1
Disassembly 1 1
Difficult or Delayed Positioning 1 1
Unraveled Material 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 31 31
Joint Dislocation 29 29
Pain 25 25
No Known Impact Or Consequence To Patient 21 21
Unspecified Infection 19 19
No Patient Involvement 13 13
No Code Available 13 13
No Consequences Or Impact To Patient 11 11
No Clinical Signs, Symptoms or Conditions 11 11
Failure of Implant 9 9
Fall 6 6
Bone Fracture(s) 5 5
Swelling 4 4
Scar Tissue 4 4
Sepsis 3 3
Reaction 3 3
Numbness 2 2
Ambulation Difficulties 2 2
Blood Loss 2 2
Hip Fracture 2 2
Osteolysis 2 2
Unequal Limb Length 2 2
Swelling/ Edema 2 2
Insufficient Information 2 2
Malunion of Bone 1 1
Limited Mobility Of The Implanted Joint 1 1
Device Embedded In Tissue or Plaque 1 1
Fibrosis 1 1
Sleep Dysfunction 1 1
Loss of Range of Motion 1 1
Local Reaction 1 1
Tinnitus 1 1
Tissue Damage 1 1
Hypovolemia 1 1
Toxicity 1 1
Headache 1 1
Hearing Loss 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Memory Loss/Impairment 1 1
Necrosis 1 1
Arthritis 1 1
Atrial Fibrillation 1 1
Emotional Changes 1 1

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