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TPLC
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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
1
MDR Year
MDR Reports
MDR Events
2019
172
172
2020
115
115
2021
116
116
2022
90
90
2023
79
79
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
225
225
Insufficient Information
107
107
Device Dislodged or Dislocated
54
54
Connection Problem
28
28
Biocompatibility
17
17
Fitting Problem
16
16
Loose or Intermittent Connection
15
15
Unstable
13
13
Incomplete or Inadequate Connection
10
10
Unintended Movement
10
10
Migration
8
8
Break
8
8
Failure to Align
7
7
Loosening of Implant Not Related to Bone-Ingrowth
7
7
Positioning Problem
6
6
Loss of Osseointegration
6
6
Defective Device
5
5
Failure to Osseointegrate
5
5
Inadequacy of Device Shape and/or Size
5
5
Degraded
4
4
Fracture
4
4
Difficult to Insert
4
4
Malposition of Device
4
4
Osseointegration Problem
4
4
Appropriate Term/Code Not Available
4
4
Patient Device Interaction Problem
4
4
Physical Resistance/Sticking
4
4
Naturally Worn
3
3
Compatibility Problem
3
3
Migration or Expulsion of Device
3
3
Positioning Failure
3
3
Flaked
2
2
Misconnection
2
2
Nonstandard Device
2
2
Patient-Device Incompatibility
2
2
Device-Device Incompatibility
2
2
No Apparent Adverse Event
2
2
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Premature Separation
1
1
Illegible Information
1
1
Inaccurate Information
1
1
Improper or Incorrect Procedure or Method
1
1
Dull, Blunt
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Integrity Problem
1
1
Mechanical Jam
1
1
Deformation Due to Compressive Stress
1
1
Calibration Problem
1
1
Device Markings/Labelling Problem
1
1
Device Damaged by Another Device
1
1
Delivered as Unsterile Product
1
1
Unsealed Device Packaging
1
1
Off-Label Use
1
1
Difficult to Remove
1
1
Device Slipped
1
1
Use of Device Problem
1
1
Crack
1
1
Misassembled
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
123
123
Unspecified Infection
104
104
Joint Dislocation
93
93
No Clinical Signs, Symptoms or Conditions
63
63
Pain
56
56
Failure of Implant
48
48
Metal Related Pathology
28
28
No Known Impact Or Consequence To Patient
27
27
Insufficient Information
24
24
Osteolysis
19
19
No Consequences Or Impact To Patient
17
17
Inadequate Osseointegration
14
14
Bone Fracture(s)
13
13
Fall
11
11
Bacterial Infection
10
10
Hip Fracture
10
10
Joint Laxity
10
10
Arthralgia
9
9
Subluxation
7
7
Ambulation Difficulties
5
5
Deformity/ Disfigurement
5
5
Inflammation
5
5
Foreign Body Reaction
5
5
Infiltration into Tissue
4
4
Loss of Range of Motion
4
4
No Information
4
4
Impaired Healing
4
4
Discomfort
4
4
Post Operative Wound Infection
4
4
Implant Pain
4
4
Swelling/ Edema
4
4
Ischemic Heart Disease
3
3
Nerve Damage
3
3
Sepsis
3
3
Scar Tissue
2
2
Local Reaction
2
2
Hematoma
2
2
Purulent Discharge
2
2
Fever
2
2
Failure to Anastomose
2
2
Wound Dehiscence
2
2
Synovitis
2
2
Thrombosis/Thrombus
2
2
Muscle/Tendon Damage
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
Osteomyelitis
1
1
Physical Asymmetry
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Convulsion/Seizure
1
1
Osteopenia/ Osteoporosis
1
1
Thromboembolism
1
1
Tissue Breakdown
1
1
Fluid Discharge
1
1
Foreign Body In Patient
1
1
Inadequate Pain Relief
1
1
Ossification
1
1
Anemia
1
1
Apnea
1
1
Aspiration/Inhalation
1
1
Hemorrhage/Bleeding
1
1
Hyperplasia
1
1
Low Blood Pressure/ Hypotension
1
1
Renal Failure
1
1
Laceration(s)
1
1
Muscular Rigidity
1
1
Pulmonary Dysfunction
1
1
Swelling
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Joint Disorder
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Smith & Nephew, Inc.
II
Jun-09-2020
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