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TPLC
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show TPLC since
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Device
prosthesis, hip, cement restrictor
Product Code
JDK
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
7
7
2016
2
2
2018
1
1
2019
13
13
2020
4
4
2021
3
3
2022
4
4
2023
7
7
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
15
15
Break
11
11
Fracture
9
9
Insufficient Information
4
4
Material Twisted/Bent
2
2
Loose or Intermittent Connection
2
2
Loss of or Failure to Bond
2
2
Entrapment of Device
2
2
Difficult to Remove
2
2
Material Deformation
2
2
Connection Problem
2
2
Naturally Worn
2
2
Migration
1
1
Detachment of Device or Device Component
1
1
Device Dislodged or Dislocated
1
1
Device-Device Incompatibility
1
1
Migration or Expulsion of Device
1
1
Mechanical Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
10
10
No Consequences Or Impact To Patient
10
10
Unspecified Infection
9
9
No Code Available
7
7
No Clinical Signs, Symptoms or Conditions
7
7
No Information
4
4
Not Applicable
2
2
Obstruction/Occlusion
2
2
Foreign Body In Patient
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Foreign Body Reaction
1
1
Burning Sensation
1
1
Osteolysis
1
1
Insufficient Information
1
1
Host-Tissue Reaction
1
1
Joint Laxity
1
1
Ambulation Difficulties
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Depuy Orthopaedics, Inc.
II
Mar-17-2011
2
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
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