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TPLC
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Device
device, fixation, proximal femoral, implant
Product Code
JDO
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
OSTEOCENTRIC TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
OSTEOCENTRIC TECHNOLOGIES D.B.A. OSTEOCENTRIC TRAUMA
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW INC.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
10
10
2020
19
19
2021
10
10
2022
3
3
2023
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
15
15
Adverse Event Without Identified Device or Use Problem
14
14
Mechanical Problem
4
4
Device-Device Incompatibility
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Fracture
2
2
Insufficient Information
2
2
Connection Problem
2
2
Appropriate Term/Code Not Available
1
1
Migration
1
1
Positioning Problem
1
1
Migration or Expulsion of Device
1
1
Delivered as Unsterile Product
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
10
10
No Code Available
8
8
No Clinical Signs, Symptoms or Conditions
7
7
Injury
7
7
Non-union Bone Fracture
4
4
Bone Fracture(s)
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
No Known Impact Or Consequence To Patient
3
3
Unspecified Infection
2
2
Pain
2
2
Not Applicable
1
1
Insufficient Information
1
1
Failure of Implant
1
1
Calcium Deposits/Calcification
1
1
Emotional Changes
1
1
Ambulation Difficulties
1
1
No Patient Involvement
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Zimmer Biomet, Inc.
II
Jan-29-2020
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