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TPLC
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show TPLC since
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2024
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Device
prosthesis, elbow, semi-constrained, cemented
Product Code
JDB
Regulation Number
888.3160
Device Class
2
Premarket Reviews
Manufacturer
Decision
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
1
SMALL BONE INNOVATIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
TORNIER INC.
SUBSTANTIALLY EQUIVALENT
3
TORNIER, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
44
44
2016
11
11
2017
26
26
2018
39
39
2019
30
30
2020
32
32
2021
23
23
2022
60
83
2023
30
30
2024
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
101
106
Insufficient Information
46
46
Loosening of Implant Not Related to Bone-Ingrowth
38
38
Device Dislodged or Dislocated
29
47
Fracture
16
16
Unstable
16
25
Osseointegration Problem
13
21
Detachment of Device or Device Component
12
12
Migration or Expulsion of Device
11
11
Mechanical Problem
10
10
Appropriate Term/Code Not Available
9
9
Naturally Worn
9
9
Loss of Osseointegration
8
8
Break
8
8
Disassembly
7
7
Loose or Intermittent Connection
6
6
Migration
6
6
Patient Device Interaction Problem
4
4
Loss of or Failure to Bond
4
4
Use of Device Problem
4
4
Improper or Incorrect Procedure or Method
3
3
Device Slipped
3
3
Unintended Movement
3
3
Packaging Problem
2
2
Malposition of Device
2
2
Device Operates Differently Than Expected
2
2
Compatibility Problem
2
2
Material Erosion
2
2
Inaccurate Information
2
2
Detachment Of Device Component
1
1
Degraded
1
1
Difficult to Insert
1
1
Misassembled
1
1
Product Quality Problem
1
1
Fitting Problem
1
1
Component Missing
1
1
Device Issue
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Positioning Problem
1
1
Protective Measures Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Missing Value Reason
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
53
57
Failure of Implant
47
47
Pain
43
43
No Information
38
38
No Code Available
34
34
Insufficient Information
23
41
Joint Laxity
21
30
Loss of Range of Motion
21
21
Implant Pain
20
20
No Known Impact Or Consequence To Patient
19
19
Bone Fracture(s)
17
17
Inadequate Osseointegration
13
21
No Clinical Signs, Symptoms or Conditions
8
8
Injury
7
7
Joint Dislocation
7
7
Swelling/ Edema
6
6
Post Operative Wound Infection
5
5
Discomfort
5
5
Tissue Damage
5
5
Inflammation
5
5
Death
4
4
Rheumatoid Arthritis
4
4
Bacterial Infection
4
4
Ossification
4
4
Neuropathy
4
4
Osteolysis
4
4
Fluid Discharge
4
4
Reaction
4
4
Patient Problem/Medical Problem
4
4
Rupture
3
3
Sepsis
3
3
Swelling
2
2
Tingling
2
2
No Consequences Or Impact To Patient
2
2
Impaired Healing
2
2
Fracture, Arm
2
2
Wound Dehiscence
2
2
Cyst(s)
2
2
Nerve Damage
2
2
Foreign Body In Patient
2
2
Post Traumatic Wound Infection
2
2
Limb Fracture
2
2
Unspecified Tissue Injury
1
1
Device Embedded In Tissue or Plaque
1
1
Undesired Nerve Stimulation
1
1
Necrosis
1
1
Fall
1
1
Foreign Body Reaction
1
1
Hypersensitivity/Allergic reaction
1
1
Adhesion(s)
1
1
Erosion
1
1
Bronchitis
1
1
Burning Sensation
1
1
Scar Tissue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
Aug-08-2018
2
Stryker Howmedica Osteonics Corp.
II
Aug-20-2015
3
Tornier, Inc
II
Aug-29-2011
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