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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, fixation, proximal femoral, implant
Product CodeJDO
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
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
Device Slipped 2 2
Delivered as Unsterile Product 2 2
Difficult To Position 2 2
Migration 2 2
Connection Problem 2 2
Separation Failure 1 1
Difficult to Advance 1 1
Unintended Movement 1 1
Positioning Problem 1 1
Use of Device Problem 1 1
Failure to Align 1 1
Device Packaging Compromised 1 1
Bent 1 1
Material Deformation 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Operates Differently Than Expected 1 1
Corroded 1 1
Device Issue 1 1
Deformation Due to Compressive Stress 1 1
Mechanical Jam 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
Arthralgia 1 1
Hip Fracture 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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