• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device device, fixation, proximal femoral, implant
Product CodeJDO
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
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
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Adverse Event Without Identified Device or Use Problem 15 15
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
Pain 3 3
No Known Impact Or Consequence To Patient 3 3
Unspecified Infection 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
-
-