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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, ankle, semi-constrained, cemented, metal/polymer
Regulation Description Ankle joint metal/polymer semi-constrained cemented prosthesis.
Product CodeHSN
Regulation Number 888.3110
Device Class 2


Premarket Reviews
ManufacturerDecision
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DT MEDTECH LLC
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
Adverse Event Without Identified Device or Use Problem 389
Insufficient Information 95
Loss of Osseointegration 45
Migration 35
Migration or Expulsion of Device 33
Loss of or Failure to Bond 26
Fracture 17
Break 15
Device Dislodged or Dislocated 15
Use of Device Problem 13
Naturally Worn 11
Malposition of device 10
Appropriate Term/Code Not Available 10
Disassembly 10
Device Operates Differently Than Expected 10
Loosening of Implant Not Related to Bone-Ingrowth 9
Failure To Adhere Or Bond 8
Unstable 8
Device Inoperable 7
Mechanical Problem 7
Patient Device Interaction Problem 5
Noise, Audible 5
Detachment of Device or device Component 4
Mechanical Jam 4
Material Erosion 3
Unintended Movement 3
Collapse 3
Difficult To Position 3
Degraded 3
Improper or Incorrect Procedure or Method 3
Positioning Failure 2
No Apparent Adverse Event 2
Device-Device Incompatibility 2
Missing Information 2
Peeled / Delaminated 2
Metal Shedding Debris 2
Positioning Problem 2
Knob 2
Locking Mechanism 1
Material Separation 1
Bent 1
Misassembled 1
Material Integrity Problem 1
Tip 1
Missing Value Reason 1
Material Twisted / Bent 1
Material Disintegration 1
Component Incompatible 1
Osseointegration Problem 1
Difficult or Delayed Positioning 1
Guide 1
Device Difficult to Setup or Prepare 1
Mechanics Altered 1
Component Missing 1
Loose or Intermittent Connection 1
Total Device Problems 842

Recalls
Manufacturer Recall Class Date Posted
1 Exactech, Inc. II Dec-06-2017
2 Integra LifeSciences Corp. II Apr-16-2019
3 Integra LifeSciences Corp. II Feb-11-2017
4 Integra LifeSciences Corp. II Jun-29-2016
5 Tornier, Inc II Aug-26-2015
6 Wright Medical Technology Inc II May-07-2020
7 Wright Medical Technology, Inc. II Nov-25-2019
8 Zimmer Biomet, Inc. II Nov-07-2019

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