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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
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 15 15
Adverse Event Without Identified Device or Use Problem 14 14
Fracture 7 7
Loss of or Failure to Bond 7 7
Migration or Expulsion of Device 6 6
Loosening of Implant Not Related to Bone-Ingrowth 6 6
Unstable 5 5
Loose or Intermittent Connection 5 5
Naturally Worn 5 5
Device Slipped 4 4
Material Erosion 3 3
Appropriate Term/Code Not Available 3 3
Device Packaging Compromised 2 2
Packaging Problem 2 2
Misassembled 2 2
Degraded 2 2
Detachment of Device or Device Component 2 2
Noise, Audible 2 2
Compatibility Problem 1 1
Delivered as Unsterile Product 1 1
Malposition of Device 1 1
Incomplete or Missing Packaging 1 1
Patient-Device Incompatibility 1 1
Difficult to Remove 1 1
Failure To Adhere Or Bond 1 1
Osseointegration Problem 1 1
Migration 1 1
Tear, Rip or Hole in Device Packaging 1 1
Metal Shedding Debris 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
Ambulation Difficulties 4 4
Insufficient Information 4 4
No Patient Involvement 4 4
Failure of Implant 4 4
Metal Related Pathology 3 3
Bone Fracture(s) 3 3
No Known Impact Or Consequence To Patient 3 3
Toxicity 3 3
No Consequences Or Impact To Patient 3 3
Muscle Weakness 2 2
Synovitis 2 2
Osteopenia/ Osteoporosis 2 2
Osteolysis 2 2
Loss of Range of Motion 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Wound Dehiscence 2 2
Swelling/ Edema 2 2
Fibrosis 2 2
Erosion 2 2
Sepsis 1 1
Inadequate Osseointegration 1 1
Test Result 1 1
Adhesion(s) 1 1
Itching Sensation 1 1
Local Reaction 1 1
Foreign Body Reaction 1 1
Ossification 1 1
Foreign Body In Patient 1 1
Rash 1 1
Muscular Rigidity 1 1
Discomfort 1 1
Death 1 1
Fall 1 1
Joint Dislocation 1 1
Unspecified Tissue Injury 1 1
Hypersensitivity/Allergic reaction 1 1

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