Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

Device Code: 4616

Product Code(s): MBH

Device Classification Information

Device Type ID4616
Device NameProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Regulation DescriptionKnee Joint Patellofemorotibial Metal/polymer Porous-coated Uncemented Prosthesis.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission Type510(k)
CFR Regulation Number888.3565 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMBH
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4616
DeviceProsthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Product CodeMBH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionKnee Joint Patellofemorotibial Metal/polymer Porous-coated Uncemented Prosthesis.
CFR Regulation Number888.3565 [🔎]
Premarket Reviews
ManufacturerDecision
ARTHREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 3
DEPUY SYNTHES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ENCORE MEDICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
ENCORE MEDICAL, L.P.
 
SUBSTANTIALLY EQUIVALENT
 1
EXACTECH, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
MATERIALISE N.V.
 
SUBSTANTIALLY EQUIVALENT
 1
MAXX ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MICROPORT ORTHOPEDICS INC.
 
SUBSTANTIALLY EQUIVALENT
 2
MICROPORT ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 4
STRYKER ORTHOPAEDICS
 
SUBSTANTIALLY EQUIVALENT
 3
TOTAL JOINT ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
UNITED ORTHOPEDIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 2
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 3
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 4
Device Problems
Insufficient Information
 1699
Adverse Event Without Identified Device Or Use Problem
 318
Fracture
 241
Break
 232
Unstable
 199
Material Integrity Problem
 176
Migration Or Expulsion Of Device
138
Loss Of Osseointegration
 122
Device Contamination With Chemical Or Other Material
 111
Mechanical Problem
 101
Packaging Problem
 92
Malposition Of Device
86
Manufacturing, Packaging Or Shipping Problem
 84
Device Operates Differently Than Expected
 82
Difficult To Insert
 80
Naturally Worn
 78
Degraded
 77
Noise, Audible
 65
Appropriate Term/Code Not Available
 60
Component Missing
58
Loose Or Intermittent Connection
 56
Material Deformation
 55
Failure To Adhere Or Bond
 46
Positioning Problem
 45
Device Dislodged Or Dislocated
 44
Scratched Material
 43
Fitting Problem
 35
Osseointegration Problem
 33
Material Discolored
 32
Detachment Of Device Component
 32
Detachment Of Device Or Device Component
 32
Device Slipped
 27
Device Packaging Compromised
 24
Migration
 24
Use Of Device Problem
 22
Crack
 21
Device Damaged Prior To Use
20
Mechanical Jam
 19
Material Distortion
 16
Corroded
16
Loosening Of Implant Not Related To Bone-Ingrowth
 15
Material Disintegration
 14
Tear, Rip Or Hole In Device Packaging
 13
Residue After Decontamination
 12
Unintended Movement
 12
Inadequacy Of Device Shape And/or Size
 11
Difficult To Position
 11
Failure To Align
 11
Melted
 11
No Apparent Adverse Event
 11
Pin
 10
Improper Or Incorrect Procedure Or Method
 10
Material Erosion
 10
Clamp
 9
Difficult To Remove
9
Pitted
 8
Loss Of Or Failure To Bond
 8
Connection Problem
 8
Material Fragmentation
 8
Off-Label Use
 8
Sticking
 8
Difficult To Open Or Remove Packaging Material
 7
Screw
 7
Disassembly
 6
Shipping Damage Or Problem
 6
Delivered As Unsterile Product
 6
Failure To Osseointegrate
 6
Mechanics Altered
 6
Device Damaged By Another Device
 6
Material Separation
 5
Defective Device
 5
Nonstandard Device
 5
Patient-Device Incompatibility
 5
Contamination / Decontamination Problem
5
Delamination
 5
Metal Shedding Debris
 5
Device Difficult To Setup Or Prepare
 4
Contamination During Use
 4
Compatibility Problem
 4
Device Expiration Issue
 4
Flaked
 4
Device Contaminated During Manufacture Or Shipping
 4
Peeled / Delaminated
 3
Adhesive
 3
Plate
 3
Device Handling Problem
 3
Disconnection
 3
Device Disinfection Or Sterilization Issue
 3
Torn Material
 3
Handpiece
 3
Device Inoperable
 3
Bent
 3
Device Reprocessing Problem
 2
Expiration Date Error
 2
Device Operational Issue
 2
Device Appears To Trigger Rejection
 2
Device Abrasion From Instrument Or Another Object
 2
Activation, Positioning Or Separation Problem
 2
Difficult To Open Or Close
 2
Deformation Due To Compressive Stress
2
Total Device Problems 5113
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 II Mar-25-2016
2
DePuy Orthopaedics, Inc.
 II Jul-20-2015
3
Howmedica Osteonics Corp.
 II Apr-24-2018
4
Howmedica Osteonics Corp.
 II Apr-20-2018
5
MicroPort Orthopedics Inc.
 I Sep-08-2016
6
Smith & Nephew, Inc.
 II Oct-22-2018
7
Smith & Nephew, Inc.
 II Jun-11-2018
8
Smith & Nephew, Inc.
 II May-21-2018
9
Stryker Howmedica Osteonics Corp.
 II Sep-13-2016
10
Stryker Howmedica Osteonics Corp.
 II Aug-11-2016
11
Stryker Howmedica Osteonics Corp.
 II Aug-14-2015
12
Stryker Howmedica Osteonics Corp.
 II Mar-16-2015
13
Zimmer Biomet, Inc.
 II Mar-14-2018
14
Zimmer Biomet, Inc.
 II Mar-14-2018
15
Zimmer Biomet, Inc.
 II Apr-25-2017
16
Zimmer Biomet, Inc.
 II Jun-07-2016
17
Zimmer Biomet, Inc.
 II Feb-22-2016
18
Zimmer Trabecular Metal Technology, Inc.
 II Jun-10-2016
19
Zimmer Trabecular Metal Technology, Inc.
 II Mar-26-2015
20
Zimmer, Inc.
 II Mar-12-2015
TPLC Last Update: 2019-04-02 20:52:51
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