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TPLC
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Device
prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer
Product Code
MBV
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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