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TPLC
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show TPLC since
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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
7
WRIGHT MEDICAL TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
15
15
2015
55
55
2016
54
54
2017
61
61
2018
112
112
2019
172
172
2020
115
115
2021
116
116
2022
90
90
2023
79
79
2024
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
270
270
Insufficient Information
178
178
Device Dislodged or Dislocated
121
121
Connection Problem
37
37
Loose or Intermittent Connection
36
36
Appropriate Term/Code Not Available
23
23
Unintended Movement
21
21
Fitting Problem
21
21
Biocompatibility
19
19
Unstable
18
18
Break
15
15
Fracture
10
10
Device Slipped
10
10
Positioning Problem
10
10
Incomplete or Inadequate Connection
10
10
Migration
8
8
Failure to Align
8
8
Malposition of Device
8
8
Difficult to Insert
8
8
Migration or Expulsion of Device
8
8
Loss of Osseointegration
7
7
Loosening of Implant Not Related to Bone-Ingrowth
7
7
Device Operates Differently Than Expected
6
6
Inadequacy of Device Shape and/or Size
6
6
Failure to Osseointegrate
5
5
Degraded
5
5
Defective Device
5
5
Naturally Worn
5
5
Osseointegration Problem
5
5
Patient Device Interaction Problem
4
4
Physical Resistance/Sticking
4
4
Mechanical Problem
4
4
Positioning Failure
3
3
Difficult to Remove
3
3
Misconnection
3
3
Nonstandard Device
3
3
No Apparent Adverse Event
3
3
Patient-Device Incompatibility
3
3
Device-Device Incompatibility
3
3
Compatibility Problem
3
3
Off-Label Use
2
2
Improper or Incorrect Procedure or Method
2
2
High Test Results
2
2
Flaked
2
2
Failure To Adhere Or Bond
1
1
Leak/Splash
1
1
Misassembled
1
1
Disconnection
1
1
Difficult or Delayed Positioning
1
1
Detachment Of Device Component
1
1
Corroded
1
1
Crack
1
1
Dull, Blunt
1
1
Use of Device Problem
1
1
Metal Shedding Debris
1
1
Material Separation
1
1
Delivered as Unsterile Product
1
1
Unsealed Device Packaging
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Integrity Problem
1
1
Mechanical Jam
1
1
Device Damaged by Another Device
1
1
Device Packaging Compromised
1
1
Deformation Due to Compressive Stress
1
1
Calibration Problem
1
1
Detachment of Device or Device Component
1
1
Device Markings/Labelling Problem
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
190
190
Unspecified Infection
142
142
Joint Dislocation
138
138
Pain
84
85
Failure of Implant
73
73
No Code Available
67
67
No Clinical Signs, Symptoms or Conditions
63
63
No Known Impact Or Consequence To Patient
53
53
Metal Related Pathology
30
30
Insufficient Information
25
25
Osteolysis
21
21
No Information
20
20
No Consequences Or Impact To Patient
20
20
Bone Fracture(s)
16
16
Inadequate Osseointegration
16
16
Fall
15
15
Hip Fracture
13
13
Bacterial Infection
11
11
Joint Laxity
10
10
Arthralgia
9
9
Inflammation
8
8
Ambulation Difficulties
7
7
Subluxation
7
7
Post Operative Wound Infection
6
6
Toxicity
6
6
Loss of Range of Motion
6
6
Foreign Body Reaction
5
5
Discomfort
5
5
Deformity/ Disfigurement
5
5
Foreign Body In Patient
5
5
Limited Mobility Of The Implanted Joint
5
5
Impaired Healing
4
4
Infiltration into Tissue
4
4
Sepsis
4
4
Swelling/ Edema
4
4
Implant Pain
4
4
Nerve Damage
3
3
Purulent Discharge
3
3
Fever
3
3
Ischemic Heart Disease
3
3
Muscle/Tendon Damage
3
3
Thrombosis/Thrombus
2
2
Test Result
2
2
Device Embedded In Tissue or Plaque
2
2
Patch Test, Abnormal Results Of
2
2
Complaint, Ill-Defined
2
2
Scar Tissue
2
2
Failure to Anastomose
2
2
Wound Dehiscence
2
2
Low Blood Pressure/ Hypotension
2
2
Hematoma
2
2
Local Reaction
2
2
Swelling
2
2
Synovitis
2
2
Unequal Limb Length
2
2
Solid Tumour
2
2
Unspecified Tissue Injury
2
2
External Prosthetic Device Pain
1
1
Skin Inflammation/ Irritation
1
1
Physical Asymmetry
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Thyroid Problems
1
1
Tissue Damage
1
1
Vomiting
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Regurgitation
1
1
Pulmonary Dysfunction
1
1
Renal Failure
1
1
Staphylococcus Aureus
1
1
Laceration(s)
1
1
Muscular Rigidity
1
1
Hemorrhage/Bleeding
1
1
Hyperplasia
1
1
Ossification
1
1
Anemia
1
1
Apnea
1
1
Arthritis
1
1
Aspiration/Inhalation
1
1
Joint Disorder
1
1
Blood Loss
1
1
Inadequate Pain Relief
1
1
Numbness
1
1
Reaction, Injection Site
1
1
Fibrosis
1
1
Not Applicable
1
1
Tissue Breakdown
1
1
Fluid Discharge
1
1
Osteopenia/ Osteoporosis
1
1
Thromboembolism
1
1
Osteomyelitis
1
1
Convulsion/Seizure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
MicroPort Orthopedics, Inc.
I
Sep-28-2015
2
Ortho Development Corporation
II
Jun-20-2011
3
Smith & Nephew Inc
II
Feb-21-2014
4
Smith & Nephew Inc
II
Aug-08-2013
5
Smith & Nephew, Inc.
II
Jun-09-2020
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