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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
Appropriate Term/Code Not Available 3 3
Material Erosion 3 3
Degraded 2 2
Misassembled 2 2
Detachment of Device or Device Component 2 2
Device Packaging Compromised 2 2
Noise, Audible 2 2
Packaging Problem 2 2
Migration 1 1
Osseointegration Problem 1 1
Compatibility Problem 1 1
Metal Shedding Debris 1 1
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Delivered as Unsterile Product 1 1
Difficult to Remove 1 1
Failure To Adhere Or Bond 1 1

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

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