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TPLC
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Device
prosthesis, hip, hemi-, acetabular, cemented, metal
Definition
Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))
Product Code
KWB
Regulation Number
888.3370
Device Class
3
MDR Year
MDR Reports
MDR Events
2014
28
28
2015
30
30
2016
3
3
2017
2
2
2018
6
6
2019
5
5
2020
9
9
2021
4
4
2022
5
5
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
16
16
Fracture
13
13
Adverse Event Without Identified Device or Use Problem
10
10
Appropriate Term/Code Not Available
6
6
Device Dislodged or Dislocated
6
6
Naturally Worn
6
6
Osseointegration Problem
5
5
Break
4
4
Mechanical Problem
4
4
Migration or Expulsion of Device
4
4
Device Slipped
4
4
Material Integrity Problem
3
3
Loose or Intermittent Connection
2
2
Loss of Osseointegration
2
2
Patient Device Interaction Problem
2
2
Metal Shedding Debris
2
2
Fitting Problem
2
2
Detachment Of Device Component
2
2
Corroded
2
2
Hole In Material
2
2
Material Erosion
2
2
Loss of or Failure to Bond
1
1
Difficult to Insert
1
1
Degraded
1
1
Component Falling
1
1
Tear, Rip or Hole in Device Packaging
1
1
Unraveled Material
1
1
Unstable
1
1
Unsealed Device Packaging
1
1
Difficult to Remove
1
1
Material Separation
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Packaging Problem
1
1
Unintended Movement
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Device Operates Differently Than Expected
1
1
Device Packaging Compromised
1
1
Expulsion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
20
20
No Code Available
20
20
No Information
12
12
No Known Impact Or Consequence To Patient
11
11
Failure of Implant
8
8
Osteolysis
7
7
Unspecified Infection
6
6
Bone Fracture(s)
4
4
Reaction
3
3
Toxicity
3
3
Injury
3
3
Joint Dislocation
3
3
Ambulation Difficulties
3
3
No Clinical Signs, Symptoms or Conditions
3
3
Necrosis
2
2
No Consequences Or Impact To Patient
2
2
Collapse
1
1
Arthralgia
1
1
Disability
1
1
Hematoma
1
1
Abscess
1
1
Debris, Bone Shedding
1
1
Inflammation
1
1
Sepsis
1
1
Spinal Column Injury
1
1
Joint Laxity
1
1
Insufficient Information
1
1
Foreign Body In Patient
1
1
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