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TPLC
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show TPLC since
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2024
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Device
prosthesis, hip, hemi-, femoral, metal ball
Product Code
LZY
Regulation Number
888.3360
Device Class
2
Premarket Reviews
Manufacturer
Decision
MEDACTA INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
46
46
2015
97
97
2016
76
76
2017
72
72
2018
67
67
2019
59
59
2020
79
79
2021
59
59
2022
65
65
2023
77
77
2024
52
52
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
357
357
Insufficient Information
251
251
Device Dislodged or Dislocated
102
102
Appropriate Term/Code Not Available
13
13
Naturally Worn
13
13
Break
4
4
Device Contaminated During Manufacture or Shipping
3
3
Migration
3
3
Inadequacy of Device Shape and/or Size
3
3
Material Deformation
2
2
Degraded
2
2
Difficult to Insert
2
2
Material Twisted/Bent
1
1
Fracture
1
1
Nonstandard Device
1
1
Improper or Incorrect Procedure or Method
1
1
Corroded
1
1
Disassembly
1
1
No Apparent Adverse Event
1
1
Loss of or Failure to Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
307
307
Pain
234
234
No Code Available
150
150
Joint Dislocation
67
67
No Information
49
50
Not Applicable
23
23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
21
21
Joint Laxity
15
15
Discomfort
13
13
No Clinical Signs, Symptoms or Conditions
12
12
Hematoma
9
9
Fall
8
8
Insufficient Information
6
6
Foreign Body Reaction
6
6
Injury
5
5
Fluid Discharge
4
4
Osteolysis
4
4
Unspecified Tissue Injury
3
3
Host-Tissue Reaction
3
3
Post Operative Wound Infection
3
3
Ambulation Difficulties
2
2
Pocket Erosion
2
2
No Consequences Or Impact To Patient
2
2
Erosion
2
2
Tissue Damage
2
2
Loss of Range of Motion
2
2
No Known Impact Or Consequence To Patient
2
2
Bone Fracture(s)
2
2
Failure of Implant
2
2
Hypersensitivity/Allergic reaction
2
2
Cardiac Arrest
1
1
Seroma
1
1
Thrombosis/Thrombus
1
1
Ossification
1
1
Edema
1
1
Swelling
1
1
Thrombosis
1
1
Muscle Weakness
1
1
Adhesion(s)
1
1
Inflammation
1
1
Pneumonia
1
1
Test Result
1
1
Heart Failure/Congestive Heart Failure
1
1
Metal Related Pathology
1
1
Joint Disorder
1
1
Arthralgia
1
1
Embolism
1
1
Phlebitis
1
1
Stroke/CVA
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Jul-12-2022
2
Smith & Nephew Inc
II
Sep-24-2009
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