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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
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
284
284
Insufficient Information
179
179
Device Dislodged or Dislocated
122
122
Connection Problem
37
37
Loose or Intermittent Connection
36
36
Appropriate Term/Code Not Available
23
23
Fitting Problem
21
21
Unintended Movement
21
21
Biocompatibility
20
20
Unstable
18
18
Break
15
15
Device Slipped
10
10
Positioning Problem
10
10
Incomplete or Inadequate Connection
10
10
Fracture
10
10
Migration
8
8
Loss of Osseointegration
8
8
Failure to Align
8
8
Difficult to Insert
8
8
Migration or Expulsion of Device
8
8
Malposition of Device
8
8
Loosening of Implant Not Related to Bone-Ingrowth
7
7
Inadequacy of Device Shape and/or Size
6
6
Device Operates Differently Than Expected
6
6
Failure to Osseointegrate
5
5
Degraded
5
5
Osseointegration Problem
5
5
Naturally Worn
5
5
Defective Device
5
5
Patient Device Interaction Problem
5
5
Physical Resistance/Sticking
4
4
Mechanical Problem
4
4
Device-Device Incompatibility
3
3
No Apparent Adverse Event
3
3
Compatibility Problem
3
3
Misconnection
3
3
Positioning Failure
3
3
Patient-Device Incompatibility
3
3
Difficult to Remove
3
3
Nonstandard Device
3
3
Flaked
2
2
Improper or Incorrect Procedure or Method
2
2
Off-Label Use
2
2
High Test Results
2
2
Mechanical Jam
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unsealed Device Packaging
1
1
Corroded
1
1
Deformation Due to Compressive Stress
1
1
Material Integrity Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
190
190
Unspecified Infection
148
148
Joint Dislocation
139
139
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
31
31
Insufficient Information
26
26
Osteolysis
21
21
No Consequences Or Impact To Patient
20
20
No Information
20
20
Bone Fracture(s)
19
19
Inadequate Osseointegration
17
17
Fall
15
15
Hip Fracture
14
14
Bacterial Infection
11
11
Joint Laxity
11
11
Arthralgia
9
9
Inflammation
8
8
Ambulation Difficulties
7
7
Subluxation
7
7
Toxicity
6
6
Loss of Range of Motion
6
6
Post Operative Wound Infection
6
6
Deformity/ Disfigurement
5
5
Discomfort
5
5
Foreign Body In Patient
5
5
Foreign Body Reaction
5
5
Implant Pain
5
5
Limited Mobility Of The Implanted Joint
5
5
Impaired Healing
4
4
Infiltration into Tissue
4
4
Sepsis
4
4
Muscle/Tendon Damage
4
4
Swelling/ Edema
4
4
Purulent Discharge
3
3
Ischemic Heart Disease
3
3
Fever
3
3
Nerve Damage
3
3
Synovitis
2
2
Hematoma
2
2
Patch Test, Abnormal Results Of
2
2
Local Reaction
2
2
Device Embedded In Tissue or Plaque
2
2
Low Blood Pressure/ Hypotension
2
2
Thrombosis/Thrombus
2
2
Test Result
2
2
Swelling
2
2
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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