Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Device Code: 4525

Product Code(s): JDI

Device Classification Information

Device Type ID4525
Device NameProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Regulation DescriptionHip Joint Metal/polymer Semi-constrained Cemented 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 Number888.3350 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeJDI
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4525
DeviceProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Product CodeJDI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHip Joint Metal/polymer Semi-constrained Cemented Prosthesis.
CFR Regulation Number888.3350 [🔎]
Premarket Reviews
ManufacturerDecision
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 3
BIOMET MANUFACTURING LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CORIN USA
 
SUBSTANTIALLY EQUIVALENT
 1
CORIN USA LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
EXCERA ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHO DEVELOPMENT
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHO DEVELOPMENT CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
RENOVIS SURGICAL TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 3
Device Problems
Insufficient Information
 9359
Device Dislodged Or Dislocated
 2973
Appropriate Term/Code Not Available
 2810
Adverse Event Without Identified Device Or Use Problem
 1633
Corroded
939
Metal Shedding Debris
 867
Naturally Worn
 795
Material Disintegration
 640
Fracture
 640
Loss Of Osseointegration
 531
Noise, Audible
 472
Migration Or Expulsion Of Device
461
Break
 369
Malposition Of Device
291
Unstable
 288
Material Erosion
 261
Loose Or Intermittent Connection
 192
Difficult To Insert
 162
Disassembly
 141
Biocompatibility
139
Loss Of Or Failure To Bond
 137
Degraded
 127
Mechanical Problem
 119
Material Deformation
 112
Material Integrity Problem
 96
Packaging Problem
 79
Failure To Adhere Or Bond
 69
Difficult To Remove
61
Osseointegration Problem
 60
Device Operates Differently Than Expected
 56
Migration
 54
Difficult To Position
 48
Positioning Problem
 45
Detachment Of Device Component
 40
Device Slipped
 39
Separation Failure
37
Inadequacy Of Device Shape And/or Size
 35
Device Packaging Compromised
 32
Detachment Of Device Or Device Component
 32
Fitting Problem
 31
Compatibility Problem
 31
Device Contamination With Chemical Or Other Material
 30
Device-Device Incompatibility
 29
Crack
 29
Tear, Rip Or Hole In Device Packaging
 27
Separation Problem
24
Failure To Osseointegrate
 21
No Apparent Adverse Event
 21
Material Discolored
 20
Loosening Of Implant Not Related To Bone-Ingrowth
 20
Device Contaminated During Manufacture Or Shipping
 19
Device Damaged By Another Device
 16
Component Missing
14
Screw
 13
Bent
 13
Device Markings / Labelling Problem
 13
Manufacturing, Packaging Or Shipping Problem
 13
Patient-Device Incompatibility
 11
Connection Problem
 10
Mechanical Jam
 10
Component Or Accessory Incompatibility
9
Patient Device Interaction Problem
 9
Ring
 8
Material Separation
 8
Unintended Movement
 8
Device Damaged Prior To Use
7
Disconnection
 7
Difficult Or Delayed Positioning
 7
Use Of Device Problem
 7
Device Appears To Trigger Rejection
 7
Label
 6
Device Disinfection Or Sterilization Issue
 6
Scratched Material
 6
Plug
 6
Material Fragmentation
 6
Entrapment Of Device
 5
Difficult To Open Or Remove Packaging Material
 5
Device Difficult To Setup Or Prepare
 5
Improper Or Incorrect Procedure Or Method
 5
Misconnection
 4
Material Twisted / Bent
 4
Defective Device
 4
Material Distortion
 4
Unsealed Device Packaging
 4
Off-Label Use
 4
Material Protrusion / Extrusion
 4
Failure To Disconnect
 3
Component Falling
 3
Ambient Noise Problem
 3
Labelling, Instructions For Use Or Training Problem
 3
Thread
 3
Cups
 3
Tip
 3
Deformation Due To Compressive Stress
3
Misassembled
 3
Delivered As Unsterile Product
 3
Particulates
 2
Heads
 2
Failure To Cut
 2
Cap
 2
Total Device Problems 25849
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 III Jun-11-2015
2
Biomet, Inc.
 II Dec-17-2014
3
Exactech, Inc.
 II Jan-17-2017
4
Howmedica Osteonics Corp.
 II Oct-11-2018
5
Smith & Nephew, Inc.
 II May-09-2018
6
Smith & Nephew, Inc.
 II Jan-11-2017
7
Stryker Howmedica Osteonics Corp.
 II Nov-09-2016
8
Stryker Howmedica Osteonics Corp.
 II Aug-11-2016
9
Stryker Howmedica Osteonics Corp.
 II Nov-17-2015
10
Stryker Howmedica Osteonics Corp.
 II Mar-03-2015
11
Zimmer Biomet, Inc.
 II Dec-04-2018
12
Zimmer Biomet, Inc.
 II Aug-14-2018
13
Zimmer Biomet, Inc.
 II Apr-27-2018
14
Zimmer Biomet, Inc.
 II Mar-14-2018
15
Zimmer Biomet, Inc.
 II Mar-14-2018
16
Zimmer Biomet, Inc.
 II Dec-29-2017
17
Zimmer Biomet, Inc.
 II Mar-27-2017
18
Zimmer Biomet, Inc.
 II Feb-22-2016
19
Zimmer Manufacturing B.V.
 II May-16-2016
20
Zimmer Manufacturing B.V.
 II Mar-12-2016
21
Zimmer Trabecular Metal Technology, Inc.
 II Jun-10-2016
22
Zimmer, Inc.
 II Oct-20-2014
23
Zimmer, Inc.
 II Aug-26-2014
24
Zimmer, Inc.
 II Feb-20-2014
TPLC Last Update: 2019-04-02 20:51:04
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