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TPLC
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show TPLC since
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2024
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Device
prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Product Code
MRA
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
14
14
12
28
17
9
18
26
16
11
17
13
18
33
19
5
MDR Year
MDR Reports
MDR Events
2014
280
280
2015
328
328
2016
367
367
2017
540
540
2018
696
696
2019
641
641
2020
371
371
2021
109
109
2022
89
89
2023
134
134
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1472
1472
Insufficient Information
476
476
Fracture
417
417
Adverse Event Without Identified Device or Use Problem
293
293
Device Dislodged or Dislocated
197
197
Noise, Audible
148
148
Appropriate Term/Code Not Available
115
115
Loss of Osseointegration
78
78
Crack
73
73
Naturally Worn
68
68
Material Twisted/Bent
57
57
Malposition of Device
47
47
Material Deformation
44
44
Migration or Expulsion of Device
39
39
Loose or Intermittent Connection
38
38
Disassembly
34
34
Osseointegration Problem
29
29
Scratched Material
27
27
Loosening of Implant Not Related to Bone-Ingrowth
25
25
Corroded
25
25
Device-Device Incompatibility
23
23
Unstable
21
21
Degraded
21
21
Difficult to Remove
19
19
Mechanical Problem
16
16
Device Operates Differently Than Expected
16
16
Difficult to Insert
14
14
Loss of or Failure to Bond
14
14
Inadequacy of Device Shape and/or Size
13
13
Metal Shedding Debris
13
13
Connection Problem
12
12
Use of Device Problem
11
11
Material Fragmentation
10
10
Patient Device Interaction Problem
10
10
Material Integrity Problem
10
10
Device Slipped
9
9
Fitting Problem
9
9
Detachment of Device or Device Component
8
8
Unintended Movement
8
8
Positioning Problem
7
7
Failure To Adhere Or Bond
7
7
Biocompatibility
6
6
Failure to Disconnect
6
6
Migration
6
6
Physical Resistance/Sticking
6
6
Mechanical Jam
5
5
Failure to Osseointegrate
5
5
Patient-Device Incompatibility
5
5
Positioning Failure
5
5
Detachment Of Device Component
4
4
Material Erosion
4
4
Unsealed Device Packaging
4
4
Device Contaminated During Manufacture or Shipping
4
4
Component Missing
4
4
Dull, Blunt
3
3
Device Inoperable
3
3
Material Discolored
3
3
Material Disintegration
3
3
Packaging Problem
3
3
Material Frayed
2
2
Bent
2
2
Peeled/Delaminated
2
2
Difficult To Position
2
2
Device Damaged by Another Device
2
2
Device Damaged Prior to Use
2
2
Improper or Incorrect Procedure or Method
2
2
Defective Device
2
2
Device Displays Incorrect Message
1
1
Separation Failure
1
1
Failure to Align
1
1
Failure to Advance
1
1
Dent in Material
1
1
Defective Component
1
1
Out-Of-Box Failure
1
1
Device Issue
1
1
Device Disinfection Or Sterilization Issue
1
1
Ambient Noise Problem
1
1
Contamination /Decontamination Problem
1
1
Material Distortion
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Contamination with Chemical or Other Material
1
1
Device Difficult to Setup or Prepare
1
1
Off-Label Use
1
1
Device Appears to Trigger Rejection
1
1
Device Abrasion From Instrument Or Another Object
1
1
Incorrect Measurement
1
1
Unexpected Therapeutic Results
1
1
Material Separation
1
1
Misconnection
1
1
Unintended Collision
1
1
Component Incompatible
1
1
Flaked
1
1
Entrapment of Device
1
1
Disconnection
1
1
Mechanics Altered
1
1
Moisture or Humidity Problem
1
1
No Pressure
1
1
Activation Problem
1
1
Separation Problem
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1156
1156
No Information
628
628
Pain
495
495
No Code Available
378
378
Unspecified Infection
216
216
No Known Impact Or Consequence To Patient
203
203
Injury
194
194
Not Applicable
137
137
Bone Fracture(s)
113
113
Joint Dislocation
96
96
Failure of Implant
72
72
Insufficient Information
69
69
No Clinical Signs, Symptoms or Conditions
68
68
Discomfort
60
60
Device Embedded In Tissue or Plaque
53
53
Inadequate Osseointegration
49
49
Foreign Body Reaction
49
49
Metal Related Pathology
42
42
Ambulation Difficulties
42
42
Osteolysis
38
38
Inflammation
38
38
Reaction
36
36
Fall
36
36
Tissue Damage
35
35
Loss of Range of Motion
28
28
Limited Mobility Of The Implanted Joint
26
26
Host-Tissue Reaction
22
22
Swelling
21
21
Test Result
20
20
Joint Disorder
16
16
Hypersensitivity/Allergic reaction
14
14
Ossification
14
14
Foreign Body In Patient
13
13
Scar Tissue
12
12
Hematoma
12
12
Joint Laxity
12
12
Necrosis
12
12
Muscle/Tendon Damage
11
11
Hip Fracture
10
10
Edema
10
10
Swelling/ Edema
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Blood Loss
9
9
Weakness
9
9
Adhesion(s)
8
8
Cyst(s)
8
8
Synovitis
8
8
Toxicity
7
7
Unspecified Tissue Injury
6
6
Death
6
6
No Patient Involvement
6
6
Post Operative Wound Infection
5
5
Thrombosis/Thrombus
5
5
Unequal Limb Length
5
5
Myocardial Infarction
5
5
Nerve Damage
4
4
Fever
4
4
Rash
4
4
Physical Asymmetry
4
4
Arthralgia
4
4
Muscular Rigidity
4
4
Limb Fracture
4
4
Thrombosis
3
3
Abscess
3
3
Skin Irritation
3
3
High Blood Pressure/ Hypertension
3
3
Bacterial Infection
3
3
Hemorrhage/Bleeding
3
3
Infarction, Cerebral
3
3
Calcium Deposits/Calcification
2
2
Numbness
2
2
Staphylococcus Aureus
2
2
Nodule
2
2
Depression
2
2
Distress
2
2
Cardiac Arrest
2
2
Chills
2
2
Subluxation
2
2
Implant Pain
2
2
Nausea
2
2
Impaired Healing
2
2
Unspecified Musculoskeletal problem
2
2
Fatigue
2
2
Sepsis
1
1
Infiltration into Tissue
1
1
Anemia
1
1
Hyperplasia
1
1
Burning Sensation
1
1
Anxiety
1
1
Fibrosis
1
1
Nervous System Injury
1
1
Malunion of Bone
1
1
Stroke/CVA
1
1
Cellulitis
1
1
Arthritis
1
1
Headache
1
1
Scarring
1
1
Vomiting
1
1
Chest Pain
1
1
Granuloma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Exactech, Inc.
II
Jun-02-2016
2
Smith & Nephew Inc
II
Apr-22-2011
3
Stryker Howmedica Osteonics Corp.
II
Aug-04-2009
4
Zimmer, Inc.
II
Feb-20-2014
5
Zimmer, Inc.
II
Feb-04-2013
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