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TPLC
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show TPLC since
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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
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
59
59
2020
79
79
2021
59
59
2022
65
65
2023
77
77
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
294
294
Device Dislodged or Dislocated
37
37
Naturally Worn
6
6
Migration
3
3
Device Contaminated During Manufacture or Shipping
3
3
Material Deformation
2
2
Break
2
2
Inadequacy of Device Shape and/or Size
2
2
Improper or Incorrect Procedure or Method
1
1
Fracture
1
1
Material Twisted/Bent
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
141
141
No Code Available
129
129
Pain
97
97
Joint Dislocation
45
45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
21
21
Joint Laxity
13
13
No Clinical Signs, Symptoms or Conditions
10
10
Discomfort
8
8
Hematoma
7
7
Foreign Body Reaction
6
6
Fluid Discharge
4
4
Fall
3
3
Injury
3
3
Insufficient Information
3
3
Unspecified Tissue Injury
3
3
Pocket Erosion
2
2
Post Operative Wound Infection
2
2
Test Result
1
1
Adhesion(s)
1
1
No Consequences Or Impact To Patient
1
1
Failure of Implant
1
1
Muscle Weakness
1
1
Heart Failure/Congestive Heart Failure
1
1
Phlebitis
1
1
Tissue Damage
1
1
Stroke/CVA
1
1
Bone Fracture(s)
1
1
Arthralgia
1
1
Thrombosis/Thrombus
1
1
Thrombosis
1
1
Wound Dehiscence
1
1
Cardiac Arrest
1
1
Pneumonia
1
1
Embolism
1
1
Hypersensitivity/Allergic reaction
1
1
Erosion
1
1
Hemorrhage/Bleeding
1
1
Seroma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Jul-12-2022
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