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TPLC
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Device
prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
Regulation Description
Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis.
Product Code
JDH
Regulation Number
888.3380
Device Class
3
MDR Year
MDR Reports
MDR Events
2020
292
292
2021
158
158
2022
75
75
2023
5
5
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
229
229
Insufficient Information
66
66
Break
44
44
Loosening of Implant Not Related to Bone-Ingrowth
42
42
Naturally Worn
40
40
Fracture
27
27
Device Dislodged or Dislocated
25
25
Biocompatibility
20
20
Unintended Movement
13
13
Loose or Intermittent Connection
10
10
Corroded
9
9
Unstable
8
8
Compatibility Problem
7
7
Loss of Osseointegration
5
5
Appropriate Term/Code Not Available
4
4
Migration
4
4
Activation, Positioning or Separation Problem
3
3
Malposition of Device
3
3
Incomplete or Inadequate Connection
3
3
Mechanical Jam
3
3
Patient Device Interaction Problem
3
3
Degraded
3
3
Osseointegration Problem
2
2
Connection Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Material Deformation
2
2
Separation Failure
2
2
Material Erosion
2
2
Crack
2
2
Migration or Expulsion of Device
2
2
Mechanical Problem
2
2
Material Separation
1
1
Device Contamination with Chemical or Other Material
1
1
Failure to Osseointegrate
1
1
Material Twisted/Bent
1
1
Use of Device Problem
1
1
Difficult to Insert
1
1
Unclear Information
1
1
Failure to Convert to Back-Up
1
1
Dull, Blunt
1
1
Fitting Problem
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Injury
181
181
No Clinical Signs, Symptoms or Conditions
95
95
Failure of Implant
59
59
Joint Dislocation
51
51
Unspecified Infection
48
48
Pain
44
44
Bone Fracture(s)
42
42
Metal Related Pathology
40
40
No Known Impact Or Consequence To Patient
22
22
Osteolysis
13
13
Inadequate Osseointegration
11
11
Insufficient Information
10
10
Thrombosis/Thrombus
10
10
Hip Fracture
10
10
Ambulation Difficulties
9
9
No Consequences Or Impact To Patient
9
9
Loss of Range of Motion
7
7
Necrosis
6
6
No Information
5
5
Implant Pain
5
5
Discomfort
5
5
Swelling/ Edema
4
4
Joint Laxity
4
4
Subluxation
4
4
Inflammation
4
4
Foreign Body In Patient
3
3
Thrombosis
3
3
Unequal Limb Length
3
3
Neuralgia
3
3
Arthralgia
2
2
Muscular Rigidity
2
2
Post Operative Wound Infection
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Ossification
2
2
Non-union Bone Fracture
2
2
Tissue Breakdown
2
2
Ventricular Fibrillation
1
1
Chest Pain
1
1
Sepsis
1
1
Hernia
1
1
No Patient Involvement
1
1
Skin Infection
1
1
Fall
1
1
Laceration(s)
1
1
Impaired Healing
1
1
Scar Tissue
1
1
Muscle/Tendon Damage
1
1
Tachycardia
1
1
No Code Available
1
1
Tissue Damage
1
1
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