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TPLC
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Device
prosthesis, shoulder, constrained, metal/metal or metal/polymer cemented
Definition
Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96
Product Code
KWR
Regulation Number
888.3640
Device Class
3
MDR Year
MDR Reports
MDR Events
2015
40
40
2016
25
25
2022
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
32
32
Device Dislodged or Dislocated
13
13
Failure To Adhere Or Bond
7
7
Appropriate Term/Code Not Available
5
5
Migration or Expulsion of Device
3
3
Malposition of Device
3
3
Fracture
3
3
Compatibility Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Loose or Intermittent Connection
1
1
Use of Device Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
18
18
No Code Available
12
12
Unspecified Infection
6
6
Bone Fracture(s)
6
6
Pain
6
6
Failure of Implant
5
5
Loss of Range of Motion
2
2
Insufficient Information
2
2
Fall
2
2
No Consequences Or Impact To Patient
2
2
Fracture, Arm
1
1
Joint Dislocation
1
1
No Known Impact Or Consequence To Patient
1
1
Reaction
1
1
Erosion
1
1
Eructate
1
1
Pulmonary Embolism
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
The Anspach Effort, Inc.
II
Jun-25-2014
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