Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

Device Code: 4526

Product Code(s): JDL

Device Classification Information

Device Type ID	4526
Device Name	Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Regulation Description	Hip Joint Metal/metal Semi-constrained, With A Cemented Acetabular Component, Prosthesis.
Regulation Medical Specialty	Orthopedic
Review Panel	Orthopedic
Premarket Review	Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type	PMA
CFR Regulation Number	888.3320 [🔎]
FDA Device Classification	Class 3 Medical Device
Product Code	JDL
GMP Exempt	No
Summary MR	Eligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Recognized Standards

11-183 ASTM F1875-98 (Reapproved 2014)
Standard Practice For Fretting Corrosion Testing Of Modular Implant Interfaces: Hip Femoral Head-bore And Cone Taper Interface
11-197 ASTM F983-86 (Reapproved 2018)
Standard Practice For Permanent Marking Of Orthopaedic Implant Components
11-199 ASTM F565-04 (Reapproved 2018)
Standard Practice For Care And Handling Of Orthopedic Implants And Instruments
11-238 ASTM F2033-12
Standard Specification For Total Hip Joint Prosthesis And Hip Endoprosthesis Bearing Surfaces Made Of Metallic, Ceramic, And Polymeric Mateirals
11-239 ASTM F2345-03 (Reapproved 2013)
Standard Test Methods For Determination Of Static And Cyclic Fatigue Strength Of Ceramic Modular Femoral Heads
11-250 ISO 14242-3 First Edition 2009-03-15
Implants For Surgery - Wear Of Total Hip-joint Prostheses - Part 3: Loading And Displacement Parameters For Orbital Bearing Type Wear Testing Machines And Corresponding Environmental Conditions For Test
11-267 ASTM F2009-00 (Reapproved 2011)
Standard Test Method For Determining The Axial Disassembly Force Of Taper Connections Of Modular Prostheses
11-277 ISO 7206-6 Second Edition 2013-11-15
Implants For Surgery - Partial And Total Hip Joint Prostheses - Part 6: Determination Of Endurance Properties Of Head And Neck Region Of Stemmed Femoral Components
11-279 ASTM F2996-13
Standard Practice For Finite Element Analysis (FEA) Of Non-Modular Metallic Orthopaedic Hip Femoral Stems
11-285 ASTM F2978-13
Guide To Optimize Scan Sequences For Clinical Diagnostic Evaluation Of Metal-on-Metal Hip Arthroplasty Devices Using Magnetic Resonance Imaging
11-286 ASTM F2979-14
Guide For Characterization Of Wear From The Articulating Surfaces In Retrieved Metal-on-Metal And Other Hard-on-Hard Hip Prostheses
11-291 ISO 14242-1 Third Edition 2014-10-15
Implants For Surgery -- Wear Of Total Hip-joint Prostheses - Part 1: Loading And Displacement Parameters For Wear-testing Machines And Corresponding Environmental Conditions For Test
11-295 ASTM F2580-13
Standard Practice For Evaluation Of Modular Connection Of Proximally Fixed Femoral Hip Prosthesis
11-299 ASTM F2068-15
Standard Specification For Femoral Prostheses - Metallic Implants
11-306 ASTM F1814-15
Standard Guide For Evaluating Modular Hip And Knee Joint Components
11-312 ISO 7206-4 Third Edition 2010-06-15
Implants For Surgery - Partial And Total Hip Joint Prostheses - Part 4: Determination Of Endurance Properties And Performance Of Stemmed Femoral Components [Including AMENDMENT 1 (2016)]
11-314 ISO 14242-2 Second Edition 2016-09-15
Implants For Surgery - Wear Of Total Hip-joint Prostheses - Part 2: Methods Of Measurement
11-320 ISO 7206-13 First Edition 2016-07-01
Implants For Surgery - Partial And Total Hip Joint Prostheses - Part 13: Determination Of Resistance To Torque Of Head Fixation Of Stemmed Femoral Components
11-337 ISO 16087 First Edition 2013-10-01
Implants For Surgery - Roentgen Stereophotogrammetric Analysis For The Assessment Of Migration Of Orthopaedic Implants
11-339 ISO 7206-2 Third Edition 2011-04-01 AMENDMENT 1 2016-09-15
Implants For Surgery - Partial And Total Hip Joint Prostheses - Part 2: Articulating Surfaces Made Of Metallic, Ceramic And Plastics Materials [Including AMENDMENT1 (2016) ]
11-340 ASTM F3018-17
Standard Guide For Assessment Of Hard-on-Hard Articulation Total Hip Replacement And Hip Resurfacing Arthroplasty Devices
11-344 ASTM F2580-18
Standard Practice For Evaluation Of Modular Connection Of Proximally Fixed Femoral Hip Prosthesis

Total Product Life Cycle

Device Type ID	4526
Device	Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Product Code	JDL
FDA Device Classification	Class 3 Medical Device
Regulation Description	Hip Joint Metal/metal Semi-constrained, With A Cemented Acetabular Component, Prosthesis.
CFR Regulation Number	888.3320 [🔎]

Device Problems
Insufficient Information	716
Device Dislodged Or Dislocated	56
Loose Or Intermittent Connection	33
Corroded	31
Break	18
Metal Shedding Debris	15
Naturally Worn	14
Adverse Event Without Identified Device Or Use Problem	12
Migration Or Expulsion Of Device	12
Noise, Audible	11
Appropriate Term/Code Not Available	10
Material Erosion	9
Unstable	8
Fracture	7
Device Operates Differently Than Expected	6
Malposition Of Device	6
Device Slipped	5
Positioning Problem	4
Material Disintegration	4
Difficult To Remove	3
Detachment Of Device Or Device Component	3
Inadequacy Of Device Shape And/or Size	3
Loss Of Osseointegration	2
Material Separation	2
Packaging Problem	2
Cups	2
Material Integrity Problem	2
Degraded	2
Disassembly	2
Delamination	1
No Apparent Adverse Event	1
Material Frayed	1
Compatibility Problem	1
Patient-Device Incompatibility	1
Computer Software Problem	1
Device Markings / Labelling Problem	1
Material Distortion	1
Loosening Of Implant Not Related To Bone-Ingrowth	1
Component Incompatible	1
Unsealed Device Packaging	1
Device Contamination With Chemical Or Other Material	1
Fitting Problem	1
Detachment Of Device Component	1
Total Device Problems	1014

Recalls
Manufacturer		Recall Class	Date Posted
1	Wright Medical Technology Inc	II	Jun-25-2015

TPLC Last Update: 2019-04-02 20:51:06