Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

Device Code: 4579

Product Code(s): KWY

Device Classification Information

Device Type ID4579
Device NameProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Regulation DescriptionHip Joint Femoral (hemi-hip) Metal/polymer 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 Number888.3390 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKWY
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4579
DeviceProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Product CodeKWY
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHip Joint Femoral (hemi-hip) Metal/polymer Cemented Or Uncemented Prosthesis.
CFR Regulation Number888.3390 [🔎]
Premarket Reviews
ManufacturerDecision
IMPLANTS INTERNATIONAL, LTD
 
SUBSTANTIALLY EQUIVALENT
1
ONKOS SURGICAL
 
SUBSTANTIALLY EQUIVALENT
1
TOTAL JOINT ORTHOPEDICS
 
SUBSTANTIALLY EQUIVALENT
1
UNITED ORTHOPEDIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
1
ZIMMER GMBH
 
SUBSTANTIALLY EQUIVALENT
1
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Insufficient Information
2027
Appropriate Term/Code Not Available
1001
Device Dislodged Or Dislocated
644
Adverse Event Without Identified Device Or Use Problem
377
Naturally Worn
222
Metal Shedding Debris
196
Corroded
177
Material Disintegration
131
Loss Of Osseointegration
118
Noise, Audible
98
Fracture
95
Material Erosion
69
Migration Or Expulsion Of Device
60
Loose Or Intermittent Connection
53
Break
49
Difficult To Insert
42
Disassembly
42
Malposition Of Device
37
Fitting Problem
30
Biocompatibility
20
Unstable
20
Loss Of Or Failure To Bond
17
Migration
14
Device Contamination With Chemical Or Other Material
13
Device Slipped
12
Detachment Of Device Or Device Component
12
Detachment Of Device Component
11
Device Operates Differently Than Expected
9
Difficult To Remove
8
Compatibility Problem
8
Material Integrity Problem
8
Osseointegration Problem
8
Difficult To Position
8
Mechanical Problem
8
Packaging Problem
7
Positioning Problem
7
Inadequacy Of Device Shape And/or Size
7
Material Deformation
6
Material Discolored
6
Failure To Osseointegrate
6
Material Separation
5
Device Damaged Prior To Use
5
Device Markings / Labelling Problem
4
Separation Failure
4
Unintended Movement
4
Bent
4
Degraded
4
Device Difficult To Setup Or Prepare
4
Use Of Device Problem
4
Connection Problem
4
Component Missing
3
No Apparent Adverse Event
3
Improper Or Incorrect Procedure Or Method
3
Device-Device Incompatibility
3
Scratched Material
3
Disconnection
3
Device Expiration Issue
3
Crack
2
Defective Device
2
Separation Problem
2
Device Contaminated During Manufacture Or Shipping
2
Device Damaged By Another Device
2
Device Packaging Compromised
2
Misconnection
2
Failure To Adhere Or Bond
2
Tear, Rip Or Hole In Device Packaging
2
Delivered As Unsterile Product
2
Contamination / Decontamination Problem
1
Difficult Or Delayed Positioning
1
Misassembled
1
Material Split, Cut Or Torn
1
Heads
1
Material Puncture / Hole
1
Gradient Increase
1
Device Abrasion From Instrument Or Another Object
1
Particulates
1
Suction Failure
1
Defective Component
1
Handpiece
1
Cups
1
Patient-Device Incompatibility
1
Device Operational Issue
1
Human-Device Interface Problem
1
Material Twisted / Bent
1
Mechanical Jam
1
Loosening Of Implant Not Related To Bone-Ingrowth
1
Positioning Failure
1
Excess Flow Or Over-Infusion
1
Material Too Rigid Or Stiff
1
Device Subassembly
1
Partial Blockage
1
Sticking
1
Loose
1
Peeled / Delaminated
1
Nonstandard Device
1
Failure To Align
1
Entrapment Of Device
1
Dull, Blunt
1
Failure To Disconnect
1
Total Device Problems 5798
Recalls
Manufacturer Recall Class Date Posted
1
Ortho Development Corporation
II Aug-17-2014
2
Smith & Nephew, Inc.
II Nov-03-2016
3
Zimmer Biomet, Inc.
II Nov-07-2018
4
Zimmer Biomet, Inc.
II Mar-14-2018
5
Zimmer Biomet, Inc.
II Feb-15-2018
6
Zimmer Biomet, Inc.
II Feb-22-2016
7
Zimmer Manufacturing B.V.
II Mar-12-2016
8
Zimmer, Inc.
II Feb-20-2014
TPLC Last Update: 2019-04-02 20:52:09

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