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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
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
Adverse Event Without Identified Device or Use Problem
78
78
Device Dislodged or Dislocated
15
15
Unstable
10
10
Appropriate Term/Code Not Available
6
6
Detachment of Device or Device Component
4
4
Insufficient Information
4
4
Loosening of Implant Not Related to Bone-Ingrowth
3
3
No Apparent Adverse Event
3
3
Difficult to Insert
3
3
Loose or Intermittent Connection
1
1
Migration or Expulsion of Device
1
1
Inadequacy of Device Shape and/or Size
1
1
Break
1
1
Difficult or Delayed Positioning
1
1
Positioning Failure
1
1
Fracture
1
1
Noise, Audible
1
1
Patient Device Interaction Problem
1
1
Naturally Worn
1
1
Migration
1
1
Material Split, Cut or Torn
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Joint Laxity
23
23
Joint Dislocation
18
18
Implant Pain
17
17
Unspecified Infection
11
11
Failure of Implant
10
10
Loss of Range of Motion
10
10
Pain
9
9
Insufficient Information
9
9
Bone Fracture(s)
6
6
Limb Fracture
5
5
No Known Impact Or Consequence To Patient
3
3
Foreign Body In Patient
3
3
Fall
3
3
Inflammation
2
2
No Consequences Or Impact To Patient
2
2
No Information
2
2
No Code Available
2
2
Metal Related Pathology
2
2
Arthralgia
2
2
Muscle/Tendon Damage
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Subluxation
1
1
Patient Problem/Medical Problem
1
1
Numbness
1
1
Confusion/ Disorientation
1
1
Urinary Frequency
1
1
Discomfort
1
1
Fracture, Arm
1
1
Paralysis
1
1
Swelling
1
1
Dizziness
1
1
Abscess
1
1
Fever
1
1
Hematoma
1
1
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