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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive
Definition For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.
Product CodePBI
Regulation Number 888.3310
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET MANUFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 26 26
2016 199 199
2017 231 231
2018 278 278
2019 245 245
2020 185 185
2021 133 133
2022 128 128
2023 255 256
2024 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Insert 468 468
Fracture 251 251
Adverse Event Without Identified Device or Use Problem 177 177
Device Dislodged or Dislocated 143 144
Insufficient Information 131 131
Positioning Failure 91 91
Difficult To Position 62 62
Component or Accessory Incompatibility 47 47
Packaging Problem 41 41
Material Deformation 39 39
Device Contaminated During Manufacture or Shipping 38 38
Detachment of Device or Device Component 38 38
Separation Failure 37 37
Fitting Problem 36 36
Difficult to Remove 29 29
Migration or Expulsion of Device 29 29
Device-Device Incompatibility 26 26
Positioning Problem 19 19
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Break 18 18
Unstable 15 15
Noise, Audible 15 15
Naturally Worn 15 15
Difficult or Delayed Separation 13 13
Material Erosion 13 13
Delivered as Unsterile Product 13 13
Tear, Rip or Hole in Device Packaging 12 12
Device Packaging Compromised 11 11
Difficult or Delayed Positioning 10 10
Appropriate Term/Code Not Available 10 10
Migration 10 10
Physical Resistance/Sticking 9 9
Unsealed Device Packaging 9 9
Malposition of Device 8 8
Mechanical Problem 7 7
Unintended Movement 7 7
Degraded 6 6
Loss of or Failure to Bond 5 5
Corroded 5 5
Peeled/Delaminated 5 5
Activation, Positioning or Separation Problem 5 5
Device Operates Differently Than Expected 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Material Twisted/Bent 5 5
Patient Device Interaction Problem 4 4
Disassembly 4 4
Accessory Incompatible 3 3
Off-Label Use 3 3
Device Contamination with Chemical or Other Material 3 3
Device Markings/Labelling Problem 3 3
Difficult to Open or Remove Packaging Material 3 3
Defective Device 3 3
Device Damaged Prior to Use 3 3
Separation Problem 3 3
Mechanical Jam 2 2
Scratched Material 2 2
Metal Shedding Debris 2 2
Sticking 2 2
Device Damaged by Another Device 2 2
Material Separation 2 2
Misassembled 2 2
Loose or Intermittent Connection 2 2
Bent 2 2
Detachment Of Device Component 2 2
Disconnection 2 2
Material Disintegration 2 2
Flaked 2 2
Filling Problem 1 1
Entrapment of Device 1 1
Material Discolored 1 1
Component Falling 1 1
Crack 1 1
Material Fragmentation 1 1
Misconnection 1 1
Nonstandard Device 1 1
Shipping Damage or Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Problem with Sterilization 1 1
Difficult to Open or Close 1 1
Compatibility Problem 1 1
Installation-Related Problem 1 1
Material Integrity Problem 1 1
Use of Device Problem 1 1
Failure to Osseointegrate 1 1
Component Missing 1 1
Failure to Align 1 1
Failure to Advance 1 1
Device Disinfection Or Sterilization Issue 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 352 352
No Known Impact Or Consequence To Patient 329 329
No Information 240 240
Pain 167 167
Joint Dislocation 139 140
No Consequences Or Impact To Patient 122 123
No Code Available 93 93
Unspecified Infection 92 92
No Patient Involvement 55 55
Bone Fracture(s) 46 46
Ambulation Difficulties 40 40
Failure of Implant 35 35
Fall 28 28
Insufficient Information 24 24
Foreign Body In Patient 23 23
Blood Loss 19 19
Device Embedded In Tissue or Plaque 18 18
Loss of Range of Motion 17 17
Wound Dehiscence 16 16
Bacterial Infection 14 14
Hematoma 14 14
Impaired Healing 14 14
Tissue Damage 11 11
Limited Mobility Of The Implanted Joint 11 11
Hemorrhage/Bleeding 11 11
Swelling 9 9
Metal Related Pathology 9 9
Patient Problem/Medical Problem 8 8
Inflammation 8 8
Scar Tissue 7 7
Death 7 7
Osteolysis 7 7
Discomfort 7 7
Hip Fracture 7 7
Subluxation 7 7
Swelling/ Edema 5 5
Reaction 5 5
Post Operative Wound Infection 5 5
Ossification 5 5
Cellulitis 4 4
Low Blood Pressure/ Hypotension 4 4
Sleep Dysfunction 4 4
Weakness 4 4
Osteopenia/ Osteoporosis 3 3
Local Reaction 3 3
Staphylococcus Aureus 3 3
Pulmonary Embolism 3 3
Host-Tissue Reaction 3 3
Anemia 3 3
Thrombosis/Thrombus 3 3
Unspecified Tissue Injury 3 3
Muscle/Tendon Damage 2 2
Unequal Limb Length 2 2
Cancer 2 2
Arrhythmia 2 2
Fatigue 2 2
Fever 2 2
Embolism 2 2
Scarring 2 2
Neuropathy 2 2
Granuloma 2 2
Lethargy 2 2
Chills 2 2
Hypovolemia 2 2
Neck Stiffness 2 2
Sweating 2 2
Numbness 1 1
Distress 1 1
Rupture 1 1
Discharge 1 1
Hot Flashes/Flushes 1 1
Claudication 1 1
Cognitive Changes 1 1
Confusion/ Disorientation 1 1
Thromboembolism 1 1
Inadequate Osseointegration 1 1
Fluid Discharge 1 1
Muscle Spasm(s) 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Rash 1 1
Seroma 1 1
Erythema 1 1
Chest Pain 1 1
Dementia 1 1
Erosion 1 1
Bruise/Contusion 1 1
Abrasion 1 1
Convulsion/Seizure 1 1
Syncope/Fainting 1 1
Peripheral Nervous Injury 1 1
Joint Laxity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jun-19-2014
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