Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
prosthesis, hip, hemi-, femoral, metal ball
Product Code
LZY
Regulation Number
888.3360
Device Class
2
Premarket Reviews
Manufacturer
Decision
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
59
59
2020
79
79
2021
59
59
2022
65
65
2023
77
77
2024
68
68
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
340
340
Device Dislodged or Dislocated
41
41
Naturally Worn
9
9
Device Contaminated During Manufacture or Shipping
3
3
Migration
3
3
Break
2
2
Degraded
2
2
Difficult to Insert
2
2
Material Deformation
2
2
Inadequacy of Device Shape and/or Size
2
2
Fracture
2
2
Off-Label Use
1
1
Insufficient Information
1
1
Material Twisted/Bent
1
1
Appropriate Term/Code Not Available
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
169
169
No Code Available
129
129
Pain
113
113
Joint Dislocation
49
49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
21
21
Joint Laxity
15
15
No Clinical Signs, Symptoms or Conditions
13
13
Discomfort
8
8
Hematoma
7
7
Foreign Body Reaction
6
6
Insufficient Information
6
6
Fall
4
4
Fluid Discharge
4
4
Unspecified Tissue Injury
3
3
Injury
3
3
Post Operative Wound Infection
3
3
Arthritis
3
3
Bone Fracture(s)
2
2
Hypersensitivity/Allergic reaction
2
2
Pocket Erosion
2
2
Seroma
1
1
Thrombosis
1
1
Tissue Damage
1
1
No Consequences Or Impact To Patient
1
1
Arthralgia
1
1
Metal Related Pathology
1
1
Test Result
1
1
Thrombosis/Thrombus
1
1
Heart Failure/Congestive Heart Failure
1
1
Failure of Implant
1
1
Hemorrhage/Bleeding
1
1
Phlebitis
1
1
Pneumonia
1
1
Muscle Weakness
1
1
Wound Dehiscence
1
1
Adhesion(s)
1
1
Erosion
1
1
Cardiac Arrest
1
1
Stroke/CVA
1
1
Embolism
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Jul-12-2022
-
-