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TPLC
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Device
prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
Regulation Description
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
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
2020
115
115
2021
116
116
2022
90
90
2023
80
80
2024
54
54
2025
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
255
255
Device Dislodged or Dislocated
30
30
Biocompatibility
21
21
Insufficient Information
21
21
Connection Problem
18
18
Fitting Problem
12
12
Incomplete or Inadequate Connection
10
10
Unintended Movement
10
10
Loosening of Implant Not Related to Bone-Ingrowth
9
9
Loss of Osseointegration
8
8
Migration
8
8
Break
7
7
Failure to Align
7
7
Failure to Osseointegrate
7
7
Positioning Problem
6
6
Loose or Intermittent Connection
5
5
Defective Device
5
5
Patient Device Interaction Problem
5
5
Osseointegration Problem
4
4
Malposition of Device
4
4
Degraded
4
4
Difficult to Insert
4
4
Inadequacy of Device Shape and/or Size
4
4
Compatibility Problem
3
3
Physical Resistance/Sticking
3
3
Naturally Worn
3
3
Positioning Failure
3
3
Nonstandard Device
2
2
Appropriate Term/Code Not Available
2
2
Fracture
2
2
No Apparent Adverse Event
2
2
Patient-Device Incompatibility
2
2
Device-Device Incompatibility
2
2
Unstable
2
2
Misconnection
1
1
Delivered as Unsterile Product
1
1
Device Damaged by Another Device
1
1
Use of Device Problem
1
1
Scratched Material
1
1
Difficult to Remove
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unsealed Device Packaging
1
1
Device Markings/Labelling Problem
1
1
Crack
1
1
Inaccurate Information
1
1
Premature Separation
1
1
Off-Label Use
1
1
Improper or Incorrect Procedure or Method
1
1
Deformation Due to Compressive Stress
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
91
91
Joint Dislocation
68
68
No Clinical Signs, Symptoms or Conditions
63
63
Failure of Implant
50
50
Injury
41
41
Pain
35
35
Metal Related Pathology
32
32
Insufficient Information
28
28
No Known Impact Or Consequence To Patient
21
21
Osteolysis
20
20
Inadequate Osseointegration
18
18
Bone Fracture(s)
18
18
Joint Laxity
13
13
Hip Fracture
11
11
Arthralgia
11
11
Fall
11
11
Bacterial Infection
10
10
Subluxation
7
7
Swelling/ Edema
7
7
Implant Pain
6
6
Ambulation Difficulties
5
5
Inflammation
5
5
Foreign Body Reaction
5
5
Deformity/ Disfigurement
5
5
Muscle/Tendon Damage
4
4
Loss of Range of Motion
4
4
Post Operative Wound Infection
4
4
Infiltration into Tissue
4
4
No Information
4
4
Impaired Healing
4
4
Ischemic Heart Disease
3
3
Thrombosis/Thrombus
3
3
Nerve Damage
3
3
Discomfort
3
3
Sepsis
3
3
No Consequences Or Impact To Patient
2
2
Purulent Discharge
2
2
Anemia
2
2
Fever
2
2
Synovitis
2
2
Hematoma
2
2
Unequal Limb Length
2
2
Unspecified Tissue Injury
2
2
Solid Tumour
2
2
Scar Tissue
2
2
Failure to Anastomose
2
2
Wound Dehiscence
2
2
Hemorrhage/Bleeding
1
1
Inadequate Pain Relief
1
1
Physical Asymmetry
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Smith & Nephew, Inc.
II
Jun-09-2020
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