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TPLC
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Device
total shoulder arthroplasty system
Definition
To treat pain and lack of function in the shoulder.
Product Code
QHQ
Regulation Number
888.3660
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
10
10
2020
21
21
2021
23
23
2022
9
9
2023
17
17
2024
28
28
Device Problems
MDRs with this Device Problem
Events in those MDRs
Loosening of Implant Not Related to Bone-Ingrowth
18
18
Patient Device Interaction Problem
18
18
Adverse Event Without Identified Device or Use Problem
17
17
Appropriate Term/Code Not Available
16
16
Loose or Intermittent Connection
13
13
Break
10
10
Insufficient Information
6
6
Degraded
6
6
Device Dislodged or Dislocated
5
5
Patient-Device Incompatibility
3
3
Output Problem
2
2
Positioning Problem
2
2
Biocompatibility
2
2
Use of Device Problem
2
2
Physical Resistance/Sticking
1
1
Fitting Problem
1
1
Device-Device Incompatibility
1
1
Failure to Advance
1
1
Noise, Audible
1
1
Material Fragmentation
1
1
Positioning Failure
1
1
Inadequacy of Device Shape and/or Size
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
27
27
Failure of Implant
25
25
Insufficient Information
13
13
No Clinical Signs, Symptoms or Conditions
10
10
No Code Available
7
7
Hypersensitivity/Allergic reaction
6
6
Loss of Range of Motion
6
6
Metal Related Pathology
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Abrasion
4
4
No Known Impact Or Consequence To Patient
3
3
Osteolysis
3
3
Joint Dislocation
2
2
Unspecified Tissue Injury
2
2
Unspecified Infection
1
1
Limited Mobility Of The Implanted Joint
1
1
Implant Pain
1
1
Abscess
1
1
Tissue Damage
1
1
Bacterial Infection
1
1
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