Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

Device Code: 4580

Product Code(s): KWZ

Device Classification Information

Device Type ID4580
Device NameProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Regulation DescriptionHip Joint Metal/polymer Constrained Cemented Or Uncemented Prosthesis.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type510(k)
CFR Regulation Number888.3310 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKWZ
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4580
DeviceProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Product CodeKWZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHip Joint Metal/polymer Constrained Cemented Or Uncemented Prosthesis.
CFR Regulation Number888.3310 [🔎]
Premarket Reviews
ManufacturerDecision
ENCORE MEDICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 2
ENCORE MEDICAL, L.P.
 
SUBSTANTIALLY EQUIVALENT
 2
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Insufficient Information
 821
Device Dislodged Or Dislocated
 640
Appropriate Term/Code Not Available
 107
Corroded
97
Fracture
 96
Migration Or Expulsion Of Device
87
Failure To Adhere Or Bond
 72
Naturally Worn
 72
Adverse Event Without Identified Device Or Use Problem
 55
Break
 51
Disassembly
 38
Unstable
 29
Malposition Of Device
25
Mechanical Problem
 19
Difficult To Insert
 14
Loose Or Intermittent Connection
 14
Fitting Problem
 14
Loss Of Osseointegration
 12
Material Erosion
 11
Scratched Material
 11
Detachment Of Device Component
 10
Material Deformation
 10
Material Integrity Problem
 9
Metal Shedding Debris
 9
Compatibility Problem
 8
Material Separation
 8
Positioning Problem
 7
Noise, Audible
 7
Loss Of Or Failure To Bond
 7
Detachment Of Device Or Device Component
 6
Device Slipped
 6
Improper Or Incorrect Procedure Or Method
 5
Material Disintegration
 5
Tear, Rip Or Hole In Device Packaging
 4
Use Of Device Problem
 4
Crack
 4
Biocompatibility
4
Separation Failure
3
Device Damaged By Another Device
 3
No Apparent Adverse Event
 3
Migration
 3
Device Operates Differently Than Expected
 3
Difficult To Remove
3
Osseointegration Problem
 2
Component Missing
2
Degraded
 2
Misassembled
 2
Connection Problem
 2
Inadequacy Of Device Shape And/or Size
 2
Dent In Material
 2
Device Damaged Prior To Use
2
Disconnection
 2
Entrapment Of Device
 1
Material Rupture
 1
Failure To Disconnect
 1
Material Distortion
 1
Device Or Device Fragments Location Unknown
 1
Device Contamination With Chemical Or Other Material
 1
Unintended Movement
 1
Locking Mechanism
 1
Component Incompatible
 1
Material Fragmentation
 1
Off-Label Use
 1
Shaft
 1
Latch
 1
Difficult Or Delayed Positioning
 1
Device Abrasion From Instrument Or Another Object
 1
Failure To Advance
 1
Failure To Osseointegrate
 1
Patient-Device Incompatibility
 1
Material Twisted / Bent
 1
Bent
 1
Total Device Problems 2454
Recalls
Manufacturer Recall Class Date Posted
1
Smith & Nephew, Inc.
 II Jun-09-2015
TPLC Last Update: 2019-04-02 20:52:10
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