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TPLC
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show TPLC since
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Device
device, fixation, proximal femoral, implant
Product Code
JDO
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMET, INC.
SUBSTANTIALLY EQUIVALENT
2
OSTEOCENTRIC TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
OSTEOCENTRIC TECHNOLOGIES D.B.A. OSTEOCENTRIC TRAUMA
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW
SUBSTANTIALLY EQUIVALENT
2
SMITH & NEPHEW INC.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
15
15
2015
19
19
2016
44
44
2017
26
26
2018
18
18
2019
10
10
2020
19
19
2021
10
10
2022
3
3
2023
5
5
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
36
36
Break
34
34
Adverse Event Without Identified Device or Use Problem
24
24
Appropriate Term/Code Not Available
21
21
Fracture
13
13
Migration or Expulsion of Device
8
8
Mechanical Problem
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Difficult to Insert
4
4
Device-Device Incompatibility
3
3
Delivered as Unsterile Product
2
2
Migration
2
2
Difficult To Position
2
2
Connection Problem
2
2
Device Slipped
2
2
Device Packaging Compromised
1
1
Failure to Align
1
1
Use of Device Problem
1
1
Material Deformation
1
1
Bent
1
1
Product Quality Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Mechanical Jam
1
1
Corroded
1
1
Device Issue
1
1
Deformation Due to Compressive Stress
1
1
Separation Failure
1
1
Difficult to Advance
1
1
Unintended Movement
1
1
Positioning Problem
1
1
Device Operates Differently Than Expected
1
1
Detachment Of Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
34
34
No Code Available
26
26
No Consequences Or Impact To Patient
19
19
Pain
18
18
No Known Impact Or Consequence To Patient
16
16
Failure of Implant
14
14
Non-union Bone Fracture
10
10
Unspecified Infection
8
8
No Clinical Signs, Symptoms or Conditions
8
8
Injury
8
8
Device Embedded In Tissue or Plaque
8
8
Bone Fracture(s)
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Hematoma
4
4
Osteolysis
4
4
Not Applicable
3
3
No Patient Involvement
3
3
Impaired Healing
2
2
Joint Dislocation
2
2
Foreign Body In Patient
2
2
Missing Value Reason
2
2
Complaint, Ill-Defined
1
1
Hip Fracture
1
1
Arthralgia
1
1
Emotional Changes
1
1
Cardiac Arrest
1
1
Insufficient Information
1
1
Sedation
1
1
Calcium Deposits/Calcification
1
1
Ambulation Difficulties
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet UK Ltd.
II
Sep-27-2018
2
Biomet, Inc.
II
Jul-19-2016
3
Howmedica Osteonics Corp.
II
Jul-28-2018
4
Zimmer Biomet, Inc.
II
Jan-29-2020
5
Zimmer, Inc.
II
Feb-20-2014
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