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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
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
13
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
71
71
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1472
1472
Insufficient Information
478
478
Fracture
440
440
Adverse Event Without Identified Device or Use Problem
307
307
Device Dislodged or Dislocated
200
200
Noise, Audible
149
149
Appropriate Term/Code Not Available
115
115
Loss of Osseointegration
79
79
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
26
26
Corroded
25
25
Device-Device Incompatibility
23
23
Degraded
23
23
Unstable
22
22
Difficult to Remove
19
19
Device Operates Differently Than Expected
16
16
Mechanical Problem
16
16
Difficult to Insert
15
15
Loss of or Failure to Bond
14
14
Metal Shedding Debris
13
13
Inadequacy of Device Shape and/or Size
13
13
Connection Problem
12
12
Use of Device Problem
11
11
Patient Device Interaction Problem
10
10
Material Fragmentation
10
10
Biocompatibility
10
10
Material Integrity Problem
10
10
Fitting Problem
9
9
Device Slipped
9
9
Detachment of Device or Device Component
8
8
Migration
8
8
Unintended Movement
8
8
Positioning Problem
7
7
Failure To Adhere Or Bond
7
7
Physical Resistance/Sticking
6
6
Failure to Disconnect
6
6
Failure to Osseointegrate
5
5
Positioning Failure
5
5
Mechanical Jam
5
5
Patient-Device Incompatibility
5
5
Unsealed Device Packaging
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1156
1156
No Information
628
628
Pain
503
503
No Code Available
378
378
Unspecified Infection
219
219
No Known Impact Or Consequence To Patient
203
203
Injury
194
194
Not Applicable
137
137
Bone Fracture(s)
114
114
Joint Dislocation
97
97
Insufficient Information
90
90
No Clinical Signs, Symptoms or Conditions
80
80
Failure of Implant
74
74
Discomfort
61
61
Device Embedded In Tissue or Plaque
53
53
Inadequate Osseointegration
51
51
Foreign Body Reaction
51
51
Metal Related Pathology
46
46
Ambulation Difficulties
43
43
Osteolysis
39
39
Inflammation
38
38
Reaction
36
36
Fall
36
36
Tissue Damage
35
35
Loss of Range of Motion
29
29
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
15
15
Ossification
15
15
Foreign Body In Patient
14
14
Joint Laxity
12
12
Scar Tissue
12
12
Necrosis
12
12
Hematoma
12
12
Muscle/Tendon Damage
11
11
Hip Fracture
11
11
Edema
10
10
Synovitis
10
10
Swelling/ Edema
10
10
Blood Loss
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Weakness
9
9
Adhesion(s)
9
9
Cyst(s)
8
8
Toxicity
7
7
Myocardial Infarction
6
6
Unspecified Tissue Injury
6
6
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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