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TPLC
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show TPLC since
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Device
prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
Product Code
MAY
Regulation Number
888.3353
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
11
11
2020
14
14
2021
24
24
2022
11
11
2023
8
8
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
30
30
Break
12
12
Adverse Event Without Identified Device or Use Problem
7
7
Device Dislodged or Dislocated
6
6
Device Contaminated During Manufacture or Shipping
5
5
Tear, Rip or Hole in Device Packaging
5
5
Naturally Worn
5
5
Unstable
4
4
Material Fragmentation
3
3
Migration
3
3
Noise, Audible
3
3
Material Deformation
2
2
Packaging Problem
2
2
Loss of or Failure to Bond
2
2
Mechanical Problem
1
1
Physical Resistance/Sticking
1
1
Crack
1
1
Insufficient Information
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Degraded
1
1
Difficult to Insert
1
1
Unraveled Material
1
1
Detachment of Device or Device Component
1
1
Appropriate Term/Code Not Available
1
1
Material Too Soft/Flexible
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
22
22
Failure of Implant
13
13
No Patient Involvement
11
11
Pain
8
8
Insufficient Information
7
7
Joint Dislocation
6
6
Bone Fracture(s)
6
6
No Known Impact Or Consequence To Patient
4
4
Unspecified Infection
3
3
Osteopenia/ Osteoporosis
3
3
Swelling/ Edema
2
2
Malunion of Bone
2
2
No Information
2
2
Scar Tissue
2
2
Unequal Limb Length
2
2
Ambulation Difficulties
1
1
Hypovolemia
1
1
Tissue Breakdown
1
1
Arthritis
1
1
Tinnitus
1
1
Hemorrhage/Bleeding
1
1
Headache
1
1
Toxicity
1
1
Fall
1
1
Swelling
1
1
Foreign Body In Patient
1
1
Post Operative Wound Infection
1
1
Electrolyte Imbalance
1
1
Blood Loss
1
1
Local Reaction
1
1
Atrial Fibrillation
1
1
Necrosis
1
1
Memory Loss/Impairment
1
1
Metal Related Pathology
1
1
No Code Available
1
1
Sepsis
1
1
Hearing Loss
1
1
Emotional Changes
1
1
Hypersensitivity/Allergic reaction
1
1
Sleep Dysfunction
1
1
High Blood Pressure/ Hypertension
1
1
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