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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
15
15
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
115
115
Adverse Event Without Identified Device or Use Problem
99
99
Device Dislodged or Dislocated
89
89
Fracture
83
83
Difficult to Insert
40
40
Unstable
37
37
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
Noise, Audible
5
5
Malposition of Device
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
Metal Shedding Debris
3
3
Device Slipped
3
3
Packaging Problem
3
3
Loosening of Implant Not Related to Bone-Ingrowth
3
3
No Apparent Adverse Event
3
3
Positioning Problem
2
2
Material Deformation
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
Patient-Device Incompatibility
2
2
Component or Accessory Incompatibility
2
2
Separation Failure
2
2
Contamination
2
2
Difficult or Delayed Positioning
2
2
Positioning Failure
1
1
Misassembled
1
1
Delivered as Unsterile Product
1
1
Device Emits Odor
1
1
Unsealed Device Packaging
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
Sticking
1
1
Material Integrity Problem
1
1
Mechanical Jam
1
1
Compatibility Problem
1
1
Device Operational Issue
1
1
Scratched Material
1
1
Temperature Problem
1
1
Patient Device Interaction Problem
1
1
Migration
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
108
108
No Code Available
93
93
Joint Dislocation
84
84
No Information
67
67
Unspecified Infection
50
50
No Known Impact Or Consequence To Patient
40
40
Loss of Range of Motion
37
37
Joint Laxity
23
23
No Consequences Or Impact To Patient
18
18
Bone Fracture(s)
18
18
Failure of Implant
17
17
Implant Pain
17
17
Limited Mobility Of The Implanted Joint
11
11
Fall
10
10
Reaction
9
9
Insufficient Information
9
9
Foreign Body In Patient
7
7
Tissue Damage
6
6
Foreign Body Reaction
5
5
Limb Fracture
5
5
Ambulation Difficulties
4
4
Scar Tissue
4
4
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
Tissue Breakdown
3
3
No Patient Involvement
3
3
Device Embedded In Tissue or Plaque
2
2
Metal Related Pathology
2
2
Nerve Damage
2
2
Arthralgia
2
2
Inflammation
2
2
Headache
2
2
Abscess
2
2
Weakness
2
2
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
Confusion/ Disorientation
1
1
Patient Problem/Medical Problem
1
1
Muscle/Tendon Damage
1
1
Subluxation
1
1
Not Applicable
1
1
No Clinical Signs, Symptoms or Conditions
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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