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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
Product Code
MBL
Regulation Number
888.3358
Device Class
2
Premarket Reviews
Manufacturer
Decision
MICROPORT ORTHOPEDICS INC.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
111
111
2019
172
172
2020
115
115
2021
118
118
2022
92
92
2023
49
49
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
227
227
Insufficient Information
148
148
Device Dislodged or Dislocated
71
71
Connection Problem
30
30
Loose or Intermittent Connection
23
23
Fitting Problem
19
19
Unstable
15
15
Unintended Movement
15
15
Biocompatibility
14
14
Break
11
11
Incomplete or Inadequate Connection
10
10
Appropriate Term/Code Not Available
9
9
Failure to Align
7
7
Defective Device
5
5
Malposition of Device
5
5
Loss of Osseointegration
5
5
Fracture
5
5
Inadequacy of Device Shape and/or Size
5
5
Migration
5
5
Physical Resistance/Sticking
4
4
Patient Device Interaction Problem
4
4
Loosening of Implant Not Related to Bone-Ingrowth
4
4
Osseointegration Problem
4
4
Positioning Problem
4
4
Difficult to Insert
4
4
Degraded
4
4
Mechanical Problem
4
4
Failure to Osseointegrate
4
4
Migration or Expulsion of Device
3
3
Compatibility Problem
3
3
No Apparent Adverse Event
3
3
Device-Device Incompatibility
2
2
Naturally Worn
2
2
Positioning Failure
2
2
Flaked
2
2
Misconnection
2
2
High Test Results
2
2
Patient-Device Incompatibility
2
2
Deformation Due to Compressive Stress
1
1
Calibration Problem
1
1
Device Markings/Labelling Problem
1
1
Device Damaged by Another Device
1
1
Dull, Blunt
1
1
Improper or Incorrect Procedure or Method
1
1
Use of Device Problem
1
1
Delivered as Unsterile Product
1
1
Off-Label Use
1
1
Difficult to Remove
1
1
Device Slipped
1
1
Crack
1
1
Misassembled
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Integrity Problem
1
1
Mechanical Jam
1
1
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Premature Separation
1
1
Illegible Information
1
1
Inaccurate Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
169
169
Unspecified Infection
113
113
Joint Dislocation
112
112
Pain
63
64
No Clinical Signs, Symptoms or Conditions
59
59
Failure of Implant
47
47
No Known Impact Or Consequence To Patient
35
35
Metal Related Pathology
23
23
Insufficient Information
21
21
Osteolysis
17
17
No Consequences Or Impact To Patient
17
17
Hip Fracture
12
12
Inadequate Osseointegration
12
12
Bone Fracture(s)
10
10
Bacterial Infection
10
10
Fall
9
9
No Information
9
9
Joint Laxity
8
8
Arthralgia
8
8
Subluxation
7
7
Ambulation Difficulties
5
5
Deformity/ Disfigurement
5
5
Post Operative Wound Infection
5
5
Limited Mobility Of The Implanted Joint
5
5
Infiltration into Tissue
5
5
Inflammation
5
5
Foreign Body Reaction
5
5
Impaired Healing
4
4
Swelling/ Edema
4
4
Ischemic Heart Disease
3
3
Loss of Range of Motion
3
3
Nerve Damage
3
3
Discomfort
3
3
Fever
3
3
Purulent Discharge
2
2
Failure to Anastomose
2
2
Hematoma
2
2
Sepsis
2
2
Synovitis
2
2
Local Reaction
2
2
Test Result
2
2
Patch Test, Abnormal Results Of
2
2
No Code Available
2
2
Unspecified Tissue Injury
2
2
Implant Pain
2
2
Unequal Limb Length
2
2
Skin Inflammation/ Irritation
1
1
Solid Tumour
1
1
Muscle/Tendon Damage
1
1
Osteomyelitis
1
1
Physical Asymmetry
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Convulsion/Seizure
1
1
Thrombosis/Thrombus
1
1
Device Embedded In Tissue or Plaque
1
1
Tissue Breakdown
1
1
Fluid Discharge
1
1
Osteopenia/ Osteoporosis
1
1
Thromboembolism
1
1
Reaction, Injection Site
1
1
Joint Disorder
1
1
Renal Failure
1
1
Scar Tissue
1
1
Pulmonary Dysfunction
1
1
Thyroid Problems
1
1
Swelling
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Hyperplasia
1
1
Low Blood Pressure/ Hypotension
1
1
Laceration(s)
1
1
Muscular Rigidity
1
1
Wound Dehiscence
1
1
Ossification
1
1
Apnea
1
1
Aspiration/Inhalation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Smith & Nephew, Inc.
II
Jun-09-2020
-
-