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TPLC
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Device
prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
Definition
Total shoulders are indicated for arthritis (osteo-, rheumatoid, traumatic), avascular necrosis, correction of functional deformity, and revision procedures.
Product Code
PAO
Regulation Number
888.3660
Device Class
2
Premarket Reviews
Manufacturer
Decision
TORNIER, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
30
30
2015
55
55
2016
63
63
2017
176
176
2018
93
93
2019
17
17
2020
7
7
2021
7
7
2022
9
9
2023
65
65
2024
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
115
115
Adverse Event Without Identified Device or Use Problem
110
110
Device Dislodged or Dislocated
89
89
Fracture
83
83
Difficult to Insert
40
40
Unstable
38
38
Migration or Expulsion of Device
20
20
Appropriate Term/Code Not Available
17
17
Detachment Of Device Component
11
11
Fitting Problem
10
10
Difficult To Position
9
9
Device Operates Differently Than Expected
8
8
Device-Device Incompatibility
8
8
Naturally Worn
8
8
Detachment of Device or Device Component
6
6
Device Damaged by Another Device
5
5
Malposition of Device
5
5
Noise, Audible
5
5
Disassembly
5
5
Material Erosion
5
5
Loose or Intermittent Connection
5
5
Mechanical Problem
4
4
Bent
4
4
Break
4
4
No Apparent Adverse Event
4
4
Loosening of Implant Not Related to Bone-Ingrowth
3
3
Packaging Problem
3
3
Device Slipped
3
3
Metal Shedding Debris
3
3
Separation Failure
2
2
Off-Label Use
2
2
Difficult to Remove
2
2
Material Separation
2
2
Inadequacy of Device Shape and/or Size
2
2
Contamination
2
2
Difficult or Delayed Positioning
2
2
Positioning Failure
2
2
Positioning Problem
2
2
Material Deformation
2
2
Patient-Device Incompatibility
2
2
Component or Accessory Incompatibility
2
2
Migration
2
2
Material Split, Cut or Torn
1
1
Patient Device Interaction Problem
1
1
Device Operational Issue
1
1
Compatibility Problem
1
1
Material Integrity Problem
1
1
Mechanical Jam
1
1
Scratched Material
1
1
Temperature Problem
1
1
Misassembled
1
1
Delivered as Unsterile Product
1
1
Device Emits Odor
1
1
Unsealed Device Packaging
1
1
Sticking
1
1
Device Difficult to Setup or Prepare
1
1
Failure To Adhere Or Bond
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Incomplete or Missing Packaging
1
1
Failure to Align
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
108
108
No Code Available
93
93
Joint Dislocation
85
85
No Information
67
67
Unspecified Infection
51
51
No Known Impact Or Consequence To Patient
40
40
Loss of Range of Motion
38
38
Joint Laxity
29
29
Implant Pain
18
18
No Consequences Or Impact To Patient
18
18
Bone Fracture(s)
18
18
Failure of Implant
17
17
Insufficient Information
11
11
Limited Mobility Of The Implanted Joint
11
11
Fall
10
10
Reaction
9
9
Foreign Body In Patient
7
7
Limb Fracture
6
6
Tissue Damage
6
6
Foreign Body Reaction
5
5
Scar Tissue
4
4
Ambulation Difficulties
4
4
Tissue Breakdown
3
3
No Patient Involvement
3
3
Swelling
3
3
Numbness
3
3
Sleep Dysfunction
3
3
Injury
3
3
Bacterial Infection
3
3
Erosion
3
3
Hematoma
3
3
Paralysis
3
3
Inflammation
2
2
Headache
2
2
Abscess
2
2
Weakness
2
2
Device Embedded In Tissue or Plaque
2
2
Nerve Damage
2
2
Arthralgia
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Metal Related Pathology
2
2
Muscle/Tendon Damage
2
2
Confusion/ Disorientation
1
1
Patient Problem/Medical Problem
1
1
Not Applicable
1
1
Hyperextension
1
1
Subluxation
1
1
Dizziness
1
1
Fracture, Arm
1
1
Urinary Tract Infection
1
1
Rupture
1
1
Urinary Frequency
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Toxicity
1
1
Fever
1
1
Burn(s)
1
1
Stroke/CVA
1
1
Cyst(s)
1
1
Death
1
1
Muscular Rigidity
1
1
Perforation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Jun-17-2013
2
Zimmer Biomet, Inc.
I
Feb-11-2017
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