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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer
Product CodeMBV
Regulation Number 888.3560
Device Class 2

MDR Year MDR Reports MDR Events
2014 5 5
2015 18 18
2016 4 4
2017 13 13
2018 5 5
2019 16 16
2020 10 10
2021 1 1
2022 6 6
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 15 15
Adverse Event Without Identified Device or Use Problem 12 12
Loss of or Failure to Bond 7 7
Fracture 7 7
Migration or Expulsion of Device 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Loose or Intermittent Connection 5 5
Unstable 5 5
Device Slipped 4 4
Naturally Worn 4 4
Material Erosion 3 3
Appropriate Term/Code Not Available 3 3
Degraded 2 2
Misassembled 2 2
Packaging Problem 2 2
Detachment of Device or Device Component 2 2
Noise, Audible 2 2
Device Packaging Compromised 2 2
Incomplete or Missing Packaging 1 1
Malposition of Device 1 1
Delivered as Unsterile Product 1 1
Metal Shedding Debris 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure To Adhere Or Bond 1 1
Compatibility Problem 1 1
Osseointegration Problem 1 1
Migration 1 1
Difficult to Remove 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 24 24
Unspecified Infection 14 14
No Information 10 10
Limited Mobility Of The Implanted Joint 9 9
No Code Available 9 9
Swelling 5 5
Reaction 5 5
No Patient Involvement 4 4
Failure of Implant 4 4
Insufficient Information 4 4
Ambulation Difficulties 4 4
Toxicity 3 3
Metal Related Pathology 3 3
No Known Impact Or Consequence To Patient 3 3
No Consequences Or Impact To Patient 3 3
Bone Fracture(s) 3 3
Loss of Range of Motion 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Muscle Weakness 2 2
Fibrosis 2 2
Osteopenia/ Osteoporosis 2 2
Synovitis 2 2
Swelling/ Edema 2 2
Erosion 2 2
Osteolysis 2 2
Fall 1 1
Hypersensitivity/Allergic reaction 1 1
Local Reaction 1 1
Discomfort 1 1
Itching Sensation 1 1
Rash 1 1
Adhesion(s) 1 1
Inadequate Osseointegration 1 1
Test Result 1 1
Ossification 1 1
Sepsis 1 1
Joint Dislocation 1 1
Death 1 1
Foreign Body In Patient 1 1
Foreign Body Reaction 1 1
Muscular Rigidity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2012
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