Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

Device Code: 4597

Product Code(s): LPH

Device Classification Information

Device Type ID4597
Device NameProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Regulation DescriptionHip Joint Metal/polymer/metal Semi-constrained 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 Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type510(k)
CFR Regulation Number888.3358 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLPH
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4597
DeviceProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Product CodeLPH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHip Joint Metal/polymer/metal Semi-constrained Porous-coated Uncemented Prosthesis.
CFR Regulation Number888.3358 [🔎]
Premarket Reviews
ManufacturerDecision
BIOMET
 
SUBSTANTIALLY EQUIVALENT
 7
BIOMET MANUFACTUTING CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
CONFORMIS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CONSENSUS ORTHOPEDICS, INC
 
SUBSTANTIALLY EQUIVALENT
 1
CORENTEC CO., LTD
 
SUBSTANTIALLY EQUIVALENT
 4
CORIN USA LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
DEPUY INTL., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
DEPUY ORTHOPAEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
EXACTECH, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
EXCERA ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
ICONACY
 
SUBSTANTIALLY EQUIVALENT
 3
LIMACORPORATE S.P.A.
 
SUBSTANTIALLY EQUIVALENT
 3
MAKO SURGICAL CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDACTA INTERNATIONAL
 
SUBSTANTIALLY EQUIVALENT
 2
MEDACTA INTERNATIONAL SA
 
SUBSTANTIALLY EQUIVALENT
 1
MERIL HEALTHCARE PVT. LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
MICROPORT ORTHOPEDICS INC.
 
SUBSTANTIALLY EQUIVALENT
 2
NOVOSOURCE INC
 
SUBSTANTIALLY EQUIVALENT
 1
OMNI
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHO DEVELOPMENT
 
SUBSTANTIALLY EQUIVALENT
 5
ORTHO DEVELOPMENT CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 4
RENOVIS SURGICAL TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
RENOVIS SURGICAL TECHNOLOGIES, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
SIGNATURE ORTHOPAEDICS PTY LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 6
STELKAST
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 6
STRYKER ORTHOPAEDICS
 
SUBSTANTIALLY EQUIVALENT
 4
TOTAL JOINT ORTHOPEDICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 3
UNITED ORTHOPEDIC CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 4
ZIMMER BIOMET
 
SUBSTANTIALLY EQUIVALENT
 6
ZIMMER, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Insufficient Information
 6393
Device Dislodged Or Dislocated
 2947
Appropriate Term/Code Not Available
 2139
Adverse Event Without Identified Device Or Use Problem
 1564
Loss Of Osseointegration
 1447
Corroded
838
Fracture
 817
Naturally Worn
 676
Disassembly
 670
Malposition Of Device
659
Migration Or Expulsion Of Device
513
Break
 463
Metal Shedding Debris
 410
Noise, Audible
 407
Loose Or Intermittent Connection
 319
Material Deformation
 305
Material Integrity Problem
 286
Mechanical Problem
 232
Material Erosion
 211
Unstable
 207
Osseointegration Problem
 189
Biocompatibility
178
Degraded
 161
Difficult To Insert
 160
Positioning Problem
 143
Material Disintegration
 126
Packaging Problem
 116
Device Operates Differently Than Expected
 108
Fitting Problem
 89
Failure To Adhere Or Bond
 83
Loss Of Or Failure To Bond
 81
Difficult To Remove
76
Manufacturing, Packaging Or Shipping Problem
 67
Detachment Of Device Or Device Component
 63
Material Separation
 61
Inadequacy Of Device Shape And/or Size
 60
Detachment Of Device Component
 58
Failure To Osseointegrate
 55
Migration
 54
Device Packaging Compromised
 51
Tear, Rip Or Hole In Device Packaging
 50
Device Slipped
 48
Scratched Material
 44
Device Contamination With Chemical Or Other Material
 43
Separation Problem
42
Material Discolored
 42
Compatibility Problem
 40
Separation Failure
39
Difficult To Position
 36
Unintended Movement
 28
No Apparent Adverse Event
 27
Use Of Device Problem
 26
Crack
 25
Material Distortion
 24
Device-Device Incompatibility
 24
Device Contaminated During Manufacture Or Shipping
 23
Mechanical Jam
 23
Bent
 23
Sticking
 20
Loosening Of Implant Not Related To Bone-Ingrowth
 17
Component Missing
16
Connection Problem
 16
Screw
 15
Material Twisted / Bent
 15
Component Or Accessory Incompatibility
15
Device Markings / Labelling Problem
 15
Dull, Blunt
 14
Delamination
 14
Patient-Device Incompatibility
 13
Tip
 12
Device Damaged By Another Device
 12
Cups
 11
Product Quality Problem
 11
Out-Of-Box Failure
 10
Physical Resistance / Sticking
 9
Device Damaged Prior To Use
9
Defective Device
 9
Delivered As Unsterile Product
 9
Disconnection
 8
Component Incompatible
 8
Material Fragmentation
 7
Misassembly By Users
 7
Mechanics Altered
 7
Difficult To Open Or Remove Packaging Material
 7
Shaft
 7
Contamination / Decontamination Problem
6
Improper Or Incorrect Procedure Or Method
 6
Misconnection
 6
Difficult Or Delayed Positioning
 5
Device Expiration Issue
 5
Nonstandard Device
 5
Entrapment Of Device
 5
Device Issue
 5
Material Protrusion / Extrusion
 5
Unsealed Device Packaging
 4
Off-Label Use
 4
Device Subassembly
 4
Flaked
 4
Failure To Disconnect
 4
Component Falling
 4
Total Device Problems 24474
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 II Aug-29-2015
2
Biomet, Inc.
 III Jun-11-2015
3
Biomet, Inc.
 II Feb-17-2015
4
CORENTEC CO., LTD
 II Mar-13-2017
5
Conformis, Inc.
 II Jan-12-2019
6
Djo Surgical
 II Mar-04-2014
7
Encore Medical, Lp
 II Jul-19-2016
8
Exactech, Inc.
 II Jan-17-2017
9
Exactech, Inc.
 II Feb-03-2014
10
Howmedica Osteonics Corp.
 II Mar-09-2018
11
OMNIlife Science Inc.
 II Jul-25-2018
12
Omnilife Science Inc.
 II Aug-21-2015
13
Signal Medical Corporation
 II Oct-22-2014
14
Smith & Nephew, Inc.
 II Mar-20-2019
15
Stryker Howmedica Osteonics Corp.
 II Jul-25-2016
16
Stryker Howmedica Osteonics Corp.
 II Nov-10-2015
17
Stryker Howmedica Osteonics Corp.
 II Sep-23-2015
18
Stryker Howmedica Osteonics Corp.
 II May-19-2015
19
Zimmer Biomet, Inc.
 II Jul-05-2018
20
Zimmer Biomet, Inc.
 II Apr-27-2018
21
Zimmer Biomet, Inc.
 II Mar-14-2018
22
Zimmer Biomet, Inc.
 II Mar-14-2018
23
Zimmer Biomet, Inc.
 II Mar-09-2018
24
Zimmer Biomet, Inc.
 II Feb-26-2018
25
Zimmer Biomet, Inc.
 II Jan-04-2018
26
Zimmer Biomet, Inc.
 II Mar-20-2017
27
Zimmer Biomet, Inc.
 II Jan-13-2017
28
Zimmer Biomet, Inc.
 II Mar-04-2016
29
Zimmer Biomet, Inc.
 II Feb-22-2016
30
Zimmer Gmbh
 II Feb-20-2015
31
Zimmer Inc.
 II Jun-26-2015
32
Zimmer Manufacturing B.V.
 II May-16-2016
33
Zimmer Manufacturing B.V.
 II Mar-12-2016
34
Zimmer Manufacturing B.V.
 II Dec-24-2014
35
Zimmer Manufacturing B.V.
 II Dec-17-2014
36
Zimmer Trabecular Metal Technology, Inc.
 II Jun-10-2016
37
Zimmer, Inc.
 II Jul-10-2014
38
Zimmer, Inc.
 II Jun-20-2014
39
Zimmer, Inc.
 II Apr-24-2014
40
Zimmer, Inc.
 II Feb-20-2014
TPLC Last Update: 2019-04-02 20:52:32
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